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

Purpose

TOPICAL PAIN RELIEF

Description

Methyl Salicylate 30% Menthol 10% Camphor 4%


Medication Information

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.

Uses

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

Purpose

TOPICAL PAIN RELIEF

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.

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

Description

Methyl Salicylate 30% Menthol 10% Camphor 4%

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

Section 51945-4

Active Ingredients

Methyl Salicylate 30%

Menthol 10%

Camphor 4%


Structured Label Content

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.

Uses (USES)

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

Purpose (PURPOSE)

TOPICAL PAIN RELIEF

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.

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

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Section 51945-4 (51945-4)

Active Ingredients (ACTIVE INGREDIENTS)

Methyl Salicylate 30%

Menthol 10%

Camphor 4%


Advanced Ingredient Data


Raw Label Data

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