drug facts

drug facts
SPL v2
SPL
SPL Set ID b6b3102a-4154-2da2-e053-2995a90ae99f
Route
topical
Published
Effective Date 2020-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (100 mg)
Inactive Ingredients
caprylhydroxamic acid coconut alkanes cannabidiol rosa moschata seed oil vanillyl butyl ether tocopherol water glyceryl monostearate coco-caprylate/caprate glyceryl caprylate sorbitan olivate glycerin dimethyl sulfone sorbitan monopalmitate cetearyl olivate cetostearyl alcohol polyoxyl 20 cetostearyl ether xanthan gum cetyl palmitate stearic acid

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-12-17
Description

Active Ingredients: Trolamine Salicylate 10%

Medication Information

Warnings and Precautions

Warnings:

  • For external use only
  • Keep out of reach of children
Active Ingredient

Active Ingredients:

Trolamine Salicylate 10%

Indications and Usage

Uses: For temporary relief of minor aches and pains of the muscles and joints (such as arthritis, backache, sprains and bruises).

Dosage and Administration

Directions:

Adults and children over 12 years of age:

• Apply generously to affected area

• massage into painful area until thoroughly absorbed into skin

• repeat as necessary, but no more than 4 times daily

Description

Active Ingredients: Trolamine Salicylate 10%

Section 50565-1

Keep out of reach of children

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

Section 50566-9

Stop use and ask a doctor if:

  • Condition worsens
  • symptoms persists for more tham 7 days or clear up and occurs again within few days.
  • Redness is present
  • irritaiotn develops
Section 50567-7

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact eith eyes or mucus membranes
  • do not apply to wounds or damaged skin
Section 50569-3

Children 12 years or younger:

• Ask a doctor

Section 51727-6

Inactive Ingredients: Water (Aqua), Coconut Alkanes*, Sorbitan Olivate*, Cetearyl Olivate*, Glycerin*, Dimethyl Sulfone, Glyceryl Stearate*,Cannabidiol (From Hemp Extract), Stearic Acid*, Cetyl Palmitate*, Rosa Moschata Seed Oil*, Cetearyl Alcohol, Ceteareth-20, Sorbitan Palmitate*, Tocopherol, Vanillyl Butyl Ether, Coco-Caprylate/Caprate*, Caprylhydroxamic acid*, Glyceryl Caprylate*, Xanthan Gum*

Section 51945-4

Manufactured for

DermaQuest®, Inc.

Hayward CA-94544

Made In USA

dermaquestinc.com

Section 53414-9

If pregnant or breat feeding

Ask a health professional before use

Section 55105-1

Purpose:

Topical Analgesic

Section 60561-8

Other Information

• Store at room temperature

ALLERGY ALERT - If prone to allergic reaction from aspirin orsalicylates, consult a doctor before use.

Structured Label Content

Warnings and Precautions (34071-1)

Warnings:

  • For external use only
  • Keep out of reach of children
Active Ingredient (55106-9)

Active Ingredients:

Trolamine Salicylate 10%

Indications and Usage (34067-9)

Uses: For temporary relief of minor aches and pains of the muscles and joints (such as arthritis, backache, sprains and bruises).

Dosage and Administration (34068-7)

Directions:

Adults and children over 12 years of age:

• Apply generously to affected area

• massage into painful area until thoroughly absorbed into skin

• repeat as necessary, but no more than 4 times daily

Section 50565-1 (50565-1)

Keep out of reach of children

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if:

  • Condition worsens
  • symptoms persists for more tham 7 days or clear up and occurs again within few days.
  • Redness is present
  • irritaiotn develops
Section 50567-7 (50567-7)

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact eith eyes or mucus membranes
  • do not apply to wounds or damaged skin
Section 50569-3 (50569-3)

Children 12 years or younger:

• Ask a doctor

Section 51727-6 (51727-6)

Inactive Ingredients: Water (Aqua), Coconut Alkanes*, Sorbitan Olivate*, Cetearyl Olivate*, Glycerin*, Dimethyl Sulfone, Glyceryl Stearate*,Cannabidiol (From Hemp Extract), Stearic Acid*, Cetyl Palmitate*, Rosa Moschata Seed Oil*, Cetearyl Alcohol, Ceteareth-20, Sorbitan Palmitate*, Tocopherol, Vanillyl Butyl Ether, Coco-Caprylate/Caprate*, Caprylhydroxamic acid*, Glyceryl Caprylate*, Xanthan Gum*

Section 51945-4 (51945-4)

Manufactured for

DermaQuest®, Inc.

Hayward CA-94544

Made In USA

dermaquestinc.com

Section 53414-9 (53414-9)

If pregnant or breat feeding

Ask a health professional before use

Section 55105-1 (55105-1)

Purpose:

Topical Analgesic

Section 60561-8 (60561-8)

Other Information

• Store at room temperature

ALLERGY ALERT - If prone to allergic reaction from aspirin orsalicylates, consult a doctor before use.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:39.379040 · Updated: 2026-03-14T23:05:33.999008