Apsm - The Goo (82503-101)

Apsm - The Goo (82503-101)
SPL v3
SPL
SPL Set ID db4c321c-8cdc-5a11-e053-2995a90a91a1
Route
TOPICAL
Published
Effective Date 2022-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (30 g) Menthol, Unspecified Form (10 g) Camphor Oil (4 g)
Inactive Ingredients
Capryloyl Glycerin/sebacic Acid Copolymer (2000 Mpa.s) Xanthan Gum Caprylhydroxamic Acid 1,2-hexanediol Propanediol Dimethyl Isosorbide Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) Stearyl Glycyrrhetinate Fd&c Yellow No. 5 Free Acid Fd&c Green No. 3 Steareth-2 Fd&c Blue No. 1 Water Steareth-21 Stearyl Alcohol Menthyl Ethylamido Oxalate Vanillyl Butyl Ether Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-30

Description

Methyl Salicylate 30% Menthol 10% Camphor 4%

Purpose

TOPICAL PAIN RELIEF


Medication Information

Purpose

TOPICAL PAIN RELIEF

Description

Methyl Salicylate 30% Menthol 10% Camphor 4%

Uses

Temporary relief of minor aches and pains of muscles and joints associated with arthritis, backache, strain, sprains, and bruises.

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

Section 51945-4

Warnings

Avoid contact with eyes. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few

days, discontinue use of this product and consult a doctor. Do not use in large quantities, particularly over raw surfaces or blistered areas.

Directions

Adults and children over 12: Apply a thin layer and massage into painful area until thoroughly absorbed. Repeat as necessary, but no more than 4 times daily. After applying, wash hands with soap and water. Children under 12: Ask a doctor.

Active Ingredients

Methyl Salicylate 30%

Menthol 10%

Camphor 4%

Inactive Ingredients

1,2-Hexanediol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Dimethyl Isosorbide, Menthyl Ethylamido Oxalate, Propanediol, Steareth-2, Steareth-21, Stearyl Alcohol, Stearyl Glycyrrhetinate, Vanillyl Butyl Ether, Water, Xanthan Gum, Blue 1, Yellow 5, Green 3


Structured Label Content

Uses (USES)

Temporary relief of minor aches and pains of muscles and joints associated with arthritis, backache, strain, sprains, and bruises.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

TOPICAL PAIN RELIEF

Warnings (WARNINGS)

Avoid contact with eyes. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few

days, discontinue use of this product and consult a doctor. Do not use in large quantities, particularly over raw surfaces or blistered areas.

Directions (DIRECTIONS)

Adults and children over 12: Apply a thin layer and massage into painful area until thoroughly absorbed. Repeat as necessary, but no more than 4 times daily. After applying, wash hands with soap and water. Children under 12: Ask a doctor.

Active Ingredients (ACTIVE INGREDIENTS)

Methyl Salicylate 30%

Menthol 10%

Camphor 4%

Inactive Ingredients (INACTIVE INGREDIENTS)

1,2-Hexanediol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Dimethyl Isosorbide, Menthyl Ethylamido Oxalate, Propanediol, Steareth-2, Steareth-21, Stearyl Alcohol, Stearyl Glycyrrhetinate, Vanillyl Butyl Ether, Water, Xanthan Gum, Blue 1, Yellow 5, Green 3


Advanced Ingredient Data


Raw Label Data

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