Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 9b3c7b34-abd9-417b-a2e9-b7e857339ff5
Route
TOPICAL
Published
Effective Date 2010-08-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tetracycline (0.03 mg)
Inactive Ingredients
Dipropylene Glycol Water Glycerin Chlorhexidine Gluconate Calcium Gluconate Methylparaben Sodium Hydroxide Sorbic Acid Magnesium Stearate Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-08-24

Description

DRUG FACTS Active Ingredient                           Purpose Tetracycline (3%) .......................  First-aid antibiotic Uses     First aid to help prevent skin infection in minor cuts, scrapes and burns   For external use only.         Keep away from children.         Do not use in the eyes or apply over large areas of the body.          May be harmful if swallowed.          In case of deep or puncture wounds, animal bites, or serious burns, consult a physician.         Stop use and consult a physician if the condition persists or gets worse.        Do not use if allergic to any ingredient listed on this label.        Do not use longer than 1 week.  Discard this product 1 week after opening bottle.      Directions Clean the affected area.  Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area and rub gently using a cotton swab.    Repeat the process three times daily.  Keep this product refrigerated to preserve effectiveness and color. Other information     This product is an OTC antibiotic drug product for human use.  This product contains no alcohol; no animal ingredients; no biological ingredients. Blended for typical skin color.  May stain cloth. Inactive ingredients    Water, glycerin, hydroxethylcellulose, chlor-hexidine gluconate, glucono delta lactone, methylparaben, sodium hydroxide, dipropylene glycol, dimethyl sulfoxide, sorbic acid, ascorbic acid, magnesium stearate, stearic acid.   Side effects Same as other tetracycline products.   See listing of side effects online at www.PhillipsCompany.4T.com/CC.pdf Report any side effects to Phillips Company, 311 Chickasaw Street, Millerton, OK USA 74750   Tel. 580-746-2430. Email:  [email protected]

Purpose

Active Ingredient                           Purpose Tetracycline (3%) .......................  First-aid antibiotic


Medication Information

Purpose



Active Ingredient                           Purpose

Tetracycline (3%) .......................  First-aid antibiotic

Description

DRUG FACTS Active Ingredient                           Purpose Tetracycline (3%) .......................  First-aid antibiotic Uses     First aid to help prevent skin infection in minor cuts, scrapes and burns   For external use only.         Keep away from children.         Do not use in the eyes or apply over large areas of the body.          May be harmful if swallowed.          In case of deep or puncture wounds, animal bites, or serious burns, consult a physician.         Stop use and consult a physician if the condition persists or gets worse.        Do not use if allergic to any ingredient listed on this label.        Do not use longer than 1 week.  Discard this product 1 week after opening bottle.      Directions Clean the affected area.  Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area and rub gently using a cotton swab.    Repeat the process three times daily.  Keep this product refrigerated to preserve effectiveness and color. Other information     This product is an OTC antibiotic drug product for human use.  This product contains no alcohol; no animal ingredients; no biological ingredients. Blended for typical skin color.  May stain cloth. Inactive ingredients    Water, glycerin, hydroxethylcellulose, chlor-hexidine gluconate, glucono delta lactone, methylparaben, sodium hydroxide, dipropylene glycol, dimethyl sulfoxide, sorbic acid, ascorbic acid, magnesium stearate, stearic acid.   Side effects Same as other tetracycline products.   See listing of side effects online at www.PhillipsCompany.4T.com/CC.pdf Report any side effects to Phillips Company, 311 Chickasaw Street, Millerton, OK USA 74750   Tel. 580-746-2430. Email:  [email protected]

Use

Uses  

  First aid to help prevent skin infection in minor cuts, scrapes and burns

  For external use only.      

  Keep away from children.      

  Do not use in the eyes or apply over large areas of the body.       

  May be harmful if swallowed.       

  In case of deep or puncture wounds, animal bites, or serious burns, consult a physician.      

  Stop use and consult a physician if the condition persists or gets worse.        Do not use if allergic to any ingredient listed on this label.      

  Do not use longer than 1 week.  Discard this product 1 week after opening bottle.

Children

 

Keep away from children.      

Discard this product 1 week after opening bottle.    

Stop Use

Stop use and consult a physician if the condition persists or gets worse.       

Do not use if allergic to any ingredient listed on this label.   

Do not use longer than 1 week.  Discard this product 1 week after opening bottle.    

Warnings

Side effects:  same as other tetracycline products.  

See listing of side effects online at www.PhillipsCompany.4T.com/CC.pdf

Report any side effects to Phillips Company, 311 Chickasaw Street, Millerton, OK USA 74750  

Tel. 580-746-2430.  Email:  [email protected]

Ask Doctor

ASK DOCTOR

   

  In case of deep or puncture wounds, animal bites, or serious burns, consult a physician.      

  Stop use and consult a physician if the condition persists or gets worse.

Do Not Use



  For external use only.      

  Keep away from children.      

  Do not use in the eyes or apply over large areas of the body.       

  May be harmful if swallowed.       

  Do not use if allergic to any ingredient listed on this label.      

  Do not use longer than 1 week.  Discard this product 1 week after opening bottle.     



Drug Facts

DRUG FACTS

Active Ingredient                           Purpose

Tetracycline (3%) .......................  First-aid antibiotic



Uses  

  First aid to help prevent skin infection in minor cuts, scrapes and burns

  For external use only.      

  Keep away from children.      

  Do not use in the eyes or apply over large areas of the body.       

  May be harmful if swallowed.       

  In case of deep or puncture wounds, animal bites, or serious burns, consult a physician.      

  Stop use and consult a physician if the condition persists or gets worse.        Do not use if allergic to any ingredient listed on this label.     

  Do not use longer than 1 week.  Discard this product 1 week after opening bottle.     



Directions

Clean the affected area.  Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area and rub gently using a cotton swab.    Repeat the process three times daily.  Keep this product refrigerated to preserve effectiveness and color.



Other information    

This product is an OTC antibiotic drug product for human use.  This product contains no alcohol; no animal ingredients; no biological ingredients. Blended for typical skin color.  May stain cloth.



Inactive ingredients   

Water, glycerin, hydroxethylcellulose, chlor-hexidine gluconate, glucono delta lactone, methylparaben, sodium hydroxide, dipropylene glycol, dimethyl sulfoxide, sorbic acid, ascorbic acid, magnesium stearate, stearic acid.  



Side effects

Same as other tetracycline products.  

See listing of side effects online at

www.PhillipsCompany.4T.com/CC.pdf

Report any side effects to Phillips Company,

311 Chickasaw Street, Millerton, OK USA 74750  

Tel. 580-746-2430.

Email:  [email protected]



When Using



  First aid to help prevent skin infection in minor cuts, scrapes and burns

  

  In case of deep or puncture wounds, animal bites, or serious burns, consult a physician.      

 

Image of Product

Image of product

Active Ingredients

Active Ingredient                           Purpose

Tetracycline (3%) .......................  First-aid antibiotic



Inactive Ingredients

Water, glycerin, hydroxethylcellulose, chlorhexidine gluconate, glucono delta lactone, methylparaben, sodium hydroxide, dipropylene glycol, dimethyl sulfoxide, sorbic acid, ascorbic acid, magnesium stearate, stearic acid.

Dosage & Administration

Clean the affected area.  Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area and rub gently using a cotton swab.    Repeat the process three times daily.  Keep this product refrigerated to preserve effectiveness and color.




Structured Label Content

Use (USE)

Uses  

  First aid to help prevent skin infection in minor cuts, scrapes and burns

  For external use only.      

  Keep away from children.      

  Do not use in the eyes or apply over large areas of the body.       

  May be harmful if swallowed.       

  In case of deep or puncture wounds, animal bites, or serious burns, consult a physician.      

  Stop use and consult a physician if the condition persists or gets worse.        Do not use if allergic to any ingredient listed on this label.      

  Do not use longer than 1 week.  Discard this product 1 week after opening bottle.

Purpose (PURPOSE)



Active Ingredient                           Purpose

Tetracycline (3%) .......................  First-aid antibiotic

Children (CHILDREN)

 

Keep away from children.      

Discard this product 1 week after opening bottle.    

Stop Use (STOP USE)

Stop use and consult a physician if the condition persists or gets worse.       

Do not use if allergic to any ingredient listed on this label.   

Do not use longer than 1 week.  Discard this product 1 week after opening bottle.    

Warnings (WARNINGS)

Side effects:  same as other tetracycline products.  

See listing of side effects online at www.PhillipsCompany.4T.com/CC.pdf

Report any side effects to Phillips Company, 311 Chickasaw Street, Millerton, OK USA 74750  

Tel. 580-746-2430.  Email:  [email protected]

Ask Doctor (ASK DOCTOR)

ASK DOCTOR

   

  In case of deep or puncture wounds, animal bites, or serious burns, consult a physician.      

  Stop use and consult a physician if the condition persists or gets worse.

Do Not Use (DO NOT USE)



  For external use only.      

  Keep away from children.      

  Do not use in the eyes or apply over large areas of the body.       

  May be harmful if swallowed.       

  Do not use if allergic to any ingredient listed on this label.      

  Do not use longer than 1 week.  Discard this product 1 week after opening bottle.     



Drug Facts (DRUG FACTS)

DRUG FACTS

Active Ingredient                           Purpose

Tetracycline (3%) .......................  First-aid antibiotic



Uses  

  First aid to help prevent skin infection in minor cuts, scrapes and burns

  For external use only.      

  Keep away from children.      

  Do not use in the eyes or apply over large areas of the body.       

  May be harmful if swallowed.       

  In case of deep or puncture wounds, animal bites, or serious burns, consult a physician.      

  Stop use and consult a physician if the condition persists or gets worse.        Do not use if allergic to any ingredient listed on this label.     

  Do not use longer than 1 week.  Discard this product 1 week after opening bottle.     



Directions

Clean the affected area.  Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area and rub gently using a cotton swab.    Repeat the process three times daily.  Keep this product refrigerated to preserve effectiveness and color.



Other information    

This product is an OTC antibiotic drug product for human use.  This product contains no alcohol; no animal ingredients; no biological ingredients. Blended for typical skin color.  May stain cloth.



Inactive ingredients   

Water, glycerin, hydroxethylcellulose, chlor-hexidine gluconate, glucono delta lactone, methylparaben, sodium hydroxide, dipropylene glycol, dimethyl sulfoxide, sorbic acid, ascorbic acid, magnesium stearate, stearic acid.  



Side effects

Same as other tetracycline products.  

See listing of side effects online at

www.PhillipsCompany.4T.com/CC.pdf

Report any side effects to Phillips Company,

311 Chickasaw Street, Millerton, OK USA 74750  

Tel. 580-746-2430.

Email:  [email protected]



When Using (WHEN USING)



  First aid to help prevent skin infection in minor cuts, scrapes and burns

  

  In case of deep or puncture wounds, animal bites, or serious burns, consult a physician.      

 

Image of Product (Image of product)

Image of product

Active Ingredients (ACTIVE INGREDIENTS)

Active Ingredient                           Purpose

Tetracycline (3%) .......................  First-aid antibiotic



Inactive Ingredients (INACTIVE INGREDIENTS)

Water, glycerin, hydroxethylcellulose, chlorhexidine gluconate, glucono delta lactone, methylparaben, sodium hydroxide, dipropylene glycol, dimethyl sulfoxide, sorbic acid, ascorbic acid, magnesium stearate, stearic acid.

Dosage & Administration (DOSAGE & ADMINISTRATION)

Clean the affected area.  Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area and rub gently using a cotton swab.    Repeat the process three times daily.  Keep this product refrigerated to preserve effectiveness and color.




Advanced Ingredient Data


Raw Label Data

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