SPL v7
SPL
SPL Set ID 48fdf9dc-05df-866d-e063-6294a90ae03a
Route
TOPICAL
Published
Effective Date 2021-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.025 g)
Inactive Ingredients
Ceteareth-12 Propylene Glycol Methylparaben Edetate Disodium Trolamine Sodium Cetostearyl Sulfate Propylparaben Water Cetostearyl Alcohol Mineral Oil .alpha.-tocopherol Stearic Acid

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-01

Description

capsaicin 0.025%

Purpose

PAIN RELIEF


Medication Information

Indications and Usage

for the temporary relief of minor aches and pains of muscles and joints associated with :

  • simple back aches
  • arithriris
  • strains
  • sprains

Purpose

PAIN RELIEF

Description

capsaicin 0.025%

Section 50570-1

for external feminine itching if you have a vaginal discharge. Consult a doctor.

for the treatment of diaper rash. Consult a doctor.

Section 51945-4

Warnings

For external use only

  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with heating pads/pack/wrap/hot water bottle or any heating elements

Questions

CALL : 248-325-4231

Directions



Children under 12 years of age consult a physician

Apply a thin layer to affected area not more than 3 to 4 times daily

Gently massage into the skin until fully absorbed

Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes

A burning sensation may occur upon initial application but generally disappears with continued use

For a severe burning discomfort, remove excess product wiht a soft cloth and mineral oil

Active Ingredient

capsaicin 0.025%

Other Information

  • Store at room temperature 59°-86°F (15°-30°C).
  • Protect from freezing.
  • Before using any medication, read all label directions. Keep carton, it contains important information.
Inactive Ingredients

cetostearyl alcohol, sodium cetostearyl sulfate, stearic acid, trolamine, mineral oil , propylene glycol, water, methyl paraben, propyl paraben, EDTA, vitamin E

When Using This Product

•avoid contact with the eyes

  • avoid contact with other mucos membranes
Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

if pregnent or nursing see the advice of health care proffessional before using.

Stop Use and Ask Your Doctor If

•the condition gets worse

• symptoms persist more than 7 days or clear up and occur again within a few days.


Structured Label Content

Indications and Usage (34067-9)

for the temporary relief of minor aches and pains of muscles and joints associated with :

  • simple back aches
  • arithriris
  • strains
  • sprains

Section 50570-1 (50570-1)

for external feminine itching if you have a vaginal discharge. Consult a doctor.

for the treatment of diaper rash. Consult a doctor.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

PAIN RELIEF

Warnings (WARNINGS)

For external use only

  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with heating pads/pack/wrap/hot water bottle or any heating elements

Questions (QUESTIONS)

CALL : 248-325-4231

Directions (DIRECTIONS)



Children under 12 years of age consult a physician

Apply a thin layer to affected area not more than 3 to 4 times daily

Gently massage into the skin until fully absorbed

Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes

A burning sensation may occur upon initial application but generally disappears with continued use

For a severe burning discomfort, remove excess product wiht a soft cloth and mineral oil

Active Ingredient (ACTIVE INGREDIENT)

capsaicin 0.025%

Other Information (OTHER INFORMATION)

  • Store at room temperature 59°-86°F (15°-30°C).
  • Protect from freezing.
  • Before using any medication, read all label directions. Keep carton, it contains important information.
Inactive Ingredients (INACTIVE INGREDIENTS)

cetostearyl alcohol, sodium cetostearyl sulfate, stearic acid, trolamine, mineral oil , propylene glycol, water, methyl paraben, propyl paraben, EDTA, vitamin E

When Using This Product (WHEN USING THIS PRODUCT)

•avoid contact with the eyes

  • avoid contact with other mucos membranes
Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

if pregnent or nursing see the advice of health care proffessional before using.

Stop Use and Ask Your Doctor If (STOP USE AND ASK YOUR DOCTOR IF)

•the condition gets worse

• symptoms persist more than 7 days or clear up and occur again within a few days.


Advanced Ingredient Data


Raw Label Data

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