Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 3a5e4a8e-20bb-4bf8-8a2e-8dfd7f2afb49
Route
TOPICAL
Published
Effective Date 2011-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-02-15

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.        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.  If not completely rubbed in after a 20-second rub-in, too much product was used.  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.  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.        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.  If not completely rubbed in after a 20-second rub-in, too much product was used.  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.  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



  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.      



Children

 

Keep away from children.      



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.   

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

  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.      

 



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.     

 



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.  If not completely rubbed in after a 20-second rub-in, too much product was used.  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.  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

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, sodium bicarbonate.

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.  If not completely rubbed in after a 20-second rub-in, too much product was used.  Repeat the process three times daily.  For best results, refrigerate this product to reduce oxidation rate; to preserve effectiveness and color (normally orange).  Discard this product if color turns black.


Structured Label Content

Use (USE)



  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.      



Purpose (PURPOSE)



Active Ingredient                           Purpose

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

Children (CHILDREN)

 

Keep away from children.      



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.   

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)

  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.      

 



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.     

 



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.  If not completely rubbed in after a 20-second rub-in, too much product was used.  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.  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)

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, sodium bicarbonate.

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.  If not completely rubbed in after a 20-second rub-in, too much product was used.  Repeat the process three times daily.  For best results, refrigerate this product to reduce oxidation rate; to preserve effectiveness and color (normally orange).  Discard this product if color turns black.


Advanced Ingredient Data


Raw Label Data

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