81683-112

81683-112
SPL v3
SPL
SPL Set ID bdee018a-2c3c-3116-e053-2a95a90ac8d8
Route
TOPICAL
Published
Effective Date 2021-03-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (36.2 g) Capsaicin (0.00724 g) Salicylic Acid (72.4 g)
Inactive Ingredients
Ammonium Acryloyldimethyltaurate/vp Copolymer Arnica Montana Flower Aloe Vera Leaf Cetostearyl Alcohol Maltodextrin Ethylhexylglycerin Water Phenoxyethanol Propylene Glycol Potassium Cetyl Phosphate .alpha.-tocopherol Acetate Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Aminomethylpropanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-18

Description

Methyl Salicylate 20% Menthol 10% Capsaicin0.002%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Methyl Salicylate 20% Menthol 10% Capsaicin0.002%

Uses:

Provides soothing heat to sore muscles and joints.

Section 50569-3

Consult a doctor and discontinue use if irritation occurs.

Ask a health professional before use if pregnant or breastfeeding.

Ask a doctor before using if you have sensitive skin.

Section 50570-1

Do not use otherwise than as directed.

Section 51945-4

Warnings:

For external use only. Avoid contact with eyes, mucous membrane or broken skin.

Directions:

Apply liberally to area of pain and massage until lotion is absorbed into the skin. Repeat 3-4 times daily. Store at 68° to 77 ℉(20° to 25℃).

Active Ingredient

Methyl Salicylate 20%

Menthol 10%

Capsaicin0.002%

Inactive Ingredients:

Aminomethyl Propanol, Aloe Barbadensis(Aloe Vera)Leaf Juice, Arnica Montana Flower Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cetearyl Alcohol, Ethylhexylglycerin, Maltodextrin, Phenoxyethanol, Propylene Glycol, Potassium Cetyl Phosphate, Tocopheryl Acetate, Water

Keep Out of Reach of Children:

In case of accidental ingestion, get medical help or call Poison Control Center right away. Not for children 5 years or younger.

When Using This Product, Do Not:

heat, microwave, add to hot water or any container where heating water may cause splattering and result in burns, use in eyes or directly on mucus membrane, take by mouth or place in nostrils, apply to wounds or damaged skin.


Structured Label Content

Uses: (USES:)

Provides soothing heat to sore muscles and joints.

Section 50569-3 (50569-3)

Consult a doctor and discontinue use if irritation occurs.

Ask a health professional before use if pregnant or breastfeeding.

Ask a doctor before using if you have sensitive skin.

Section 50570-1 (50570-1)

Do not use otherwise than as directed.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Topical Analgesic

Warnings: (WARNINGS:)

For external use only. Avoid contact with eyes, mucous membrane or broken skin.

Directions: (DIRECTIONS:)

Apply liberally to area of pain and massage until lotion is absorbed into the skin. Repeat 3-4 times daily. Store at 68° to 77 ℉(20° to 25℃).

Active Ingredient (ACTIVE INGREDIENT)

Methyl Salicylate 20%

Menthol 10%

Capsaicin0.002%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Aminomethyl Propanol, Aloe Barbadensis(Aloe Vera)Leaf Juice, Arnica Montana Flower Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cetearyl Alcohol, Ethylhexylglycerin, Maltodextrin, Phenoxyethanol, Propylene Glycol, Potassium Cetyl Phosphate, Tocopheryl Acetate, Water

Keep Out of Reach of Children: (Keep out of reach of children:)

In case of accidental ingestion, get medical help or call Poison Control Center right away. Not for children 5 years or younger.

When Using This Product, Do Not: (When using this product, do not:)

heat, microwave, add to hot water or any container where heating water may cause splattering and result in burns, use in eyes or directly on mucus membrane, take by mouth or place in nostrils, apply to wounds or damaged skin.


Advanced Ingredient Data


Raw Label Data

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