SPL v1
SPL
SPL Set ID 1500fac5-8c0c-e6cd-e063-6394a90a705f
Route
TOPICAL
Published
Effective Date 2024-03-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.013 g)
Inactive Ingredients
Acyclovir Polyacrylic Acid (300000 Mw) Polyacrylic Acid (800000 Mw) Dihydroxyaluminum Aminoacetate Glycerin Water Dmdm Hydantoin Edetate Disodium Anhydrous Sodium Polyacrylate (8000 Mw) Sodium Acryloyldimethyltaurate-acrylamide Copolymer (1:1; 90000-150000 Mpa.s) Tartaric Acid Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-31

Description

Capsaicin 0.013 %

Purpose

Topical analgesic

Storage and Handling

 Avoid storing product in direct sunlight  Protect product from excessive moisture


Medication Information

Purpose

Topical analgesic

Storage and Handling

 Avoid storing product in direct sunlight

 Protect product from excessive moisture

Description

Capsaicin 0.013 %

Use

For temporary relief of minor pain associated with:

arthritis,

simple backache,

strains,

sprains,

bruises

Section 51945-4

Warnings

For external use only.

Directions

Adults and children 12 years of age and older:

 Clean and dry affected area

 Remove film from patch and apply to the skin

 Apply 1 patch at a time to the affected area, not more than 3 to 4 times daily.

 Remove patch from the skin after at most 8-hour application.

Children under 12 years of age: consult a doctor

Do Not Use

 On wounds or damaged skin

With a heating pad

Active Ingredient(s)

Capsaicin 0.013 %

Inactive Ingredients

Acyclovir, Dihydroxyaluminum aminoacetetel, DMDM hydantoin, Edetate Disodium Anhydrous, Glycerin, Polyacrylic acid, Sodium polyacrylate, Sodium Acryloyldimethyltaurate-acrylamide copolymer, Tartaric acid, Titanium dioxide, Water

When Using This Product:

 Use only as directed

 Do not bandage tightly

 Avoid contact with eyes, mucous membranes or rashes

 Discontinue use at least 1 hour before a bath or shower

 Do not use immediately after a bath or shower

If Pregnant Or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use and Ask A Doctor If:

 Condition worsens, Symptoms persist for more than 7 days or clear up and occur again within a few days.

 Redness is present or irritation or rash develops.

 A sever burning sensation occurs.


Structured Label Content

Use

For temporary relief of minor pain associated with:

arthritis,

simple backache,

strains,

sprains,

bruises

Section 51945-4 (51945-4)

Purpose

Topical analgesic

Warnings

For external use only.

Directions

Adults and children 12 years of age and older:

 Clean and dry affected area

 Remove film from patch and apply to the skin

 Apply 1 patch at a time to the affected area, not more than 3 to 4 times daily.

 Remove patch from the skin after at most 8-hour application.

Children under 12 years of age: consult a doctor

Do Not Use (Do not use)

 On wounds or damaged skin

With a heating pad

Active Ingredient(s)

Capsaicin 0.013 %

Inactive Ingredients (Inactive ingredients)

Acyclovir, Dihydroxyaluminum aminoacetetel, DMDM hydantoin, Edetate Disodium Anhydrous, Glycerin, Polyacrylic acid, Sodium polyacrylate, Sodium Acryloyldimethyltaurate-acrylamide copolymer, Tartaric acid, Titanium dioxide, Water

Storage and Handling (STORAGE AND HANDLING)

 Avoid storing product in direct sunlight

 Protect product from excessive moisture

When Using This Product: (When using this product:)

 Use only as directed

 Do not bandage tightly

 Avoid contact with eyes, mucous membranes or rashes

 Discontinue use at least 1 hour before a bath or shower

 Do not use immediately after a bath or shower

If Pregnant Or Breast Feeding (If pregnant or breast feeding)

ask a health professional before use.

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.

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)

 Condition worsens, Symptoms persist for more than 7 days or clear up and occur again within a few days.

 Redness is present or irritation or rash develops.

 A sever burning sensation occurs.


Advanced Ingredient Data


Raw Label Data

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