Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID b3ac69c7-5df7-4f47-a3a7-8461892b4276
Route
TOPICAL
Published
Effective Date 2017-11-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (100 mg)
Inactive Ingredients
Disodium Acetyl Glucosamine Phosphate Butylene Glycol Ceteareth-2 Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Dimethicone Dimethyl Sulfone Edetate Disodium Glyceryl Stearate Citrate N-(1,3-bis(hydroxymethyl)-2,5-dioxo-4-imidazolidinyl)-n,n'-bis(hydroxymethyl)urea Isopropyl Palmitate Lecithin, Soybean Peg-100 Stearate Phenoxyethanol Vanillyl Butyl Ether Water Xanthan Gum Tocopherol Medium-chain Triglycerides

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-11-27

Description

Active Ingredients: Trolamine Salicylate - 10%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Uses: For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains and bruises. 

Dosage and Administration

Contains Gradual Heating Sensation. Adults and Children 12 years of age and older: use no more than 3-4 times daily. Before Activity-Massage onto muscles and joints 10-30 minutes before to warm up. After - Apply cream to sore or injured areas immediately after activity or after showering. Wash hands thoroughly with soap and water after use

Description

Active Ingredients: Trolamine Salicylate - 10%

Section 50565-1

Keep out of reach of children.

Section 50566-9

If pain persist more than 7 days or redness or irritation is present or in condition affecting children under 12 years of age, consult a physician immediately.

Section 50567-7

When using this product: Avoid contact w ith eyes or mucous membranes; if contacts occurs, flush with water for 15 minutes. Do not apply to wounds or damaged skin.

Section 50569-3

Ask a doctor before use if you have a propensity for allergic reactions to aspirin or salicylate.

Section 51727-6

Inactive ingredients

Acetyl Glucosamine, Butylene Glycol, Capriylic/ Capric Triglyceride, Ceteareth-20, Cetearyl Alcohol,Cyclopentasilaxane, Dimethicone, Dimethyl Sulfone (MSM), Disodium EDTA, Fragrance, Glyceryl Stearate, Imidazolidinyl Uraea, Isopropyl Palmitate, Lecithine, PEG-100 Stearate, Phenoxy ethanol, Potassium Sorbitate, Tocopheryl Acetate, Vanillyl Butyl Ethar, Water, Xanthan Gum. 

Section 51945-4

Distributed by:

Flex Power Inc.

Berkeley, CA 94710

Section 55105-1

Purpose:

Topical Analgesic

Section 55106-9

Active Ingredients:

Trolamine Salicylate - 10%


Structured Label Content

Indications and Usage (34067-9)

Uses: For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains and bruises. 

Dosage and Administration (34068-7)

Contains Gradual Heating Sensation. Adults and Children 12 years of age and older: use no more than 3-4 times daily. Before Activity-Massage onto muscles and joints 10-30 minutes before to warm up. After - Apply cream to sore or injured areas immediately after activity or after showering. Wash hands thoroughly with soap and water after use

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

If pain persist more than 7 days or redness or irritation is present or in condition affecting children under 12 years of age, consult a physician immediately.

Section 50567-7 (50567-7)

When using this product: Avoid contact w ith eyes or mucous membranes; if contacts occurs, flush with water for 15 minutes. Do not apply to wounds or damaged skin.

Section 50569-3 (50569-3)

Ask a doctor before use if you have a propensity for allergic reactions to aspirin or salicylate.

Section 51727-6 (51727-6)

Inactive ingredients

Acetyl Glucosamine, Butylene Glycol, Capriylic/ Capric Triglyceride, Ceteareth-20, Cetearyl Alcohol,Cyclopentasilaxane, Dimethicone, Dimethyl Sulfone (MSM), Disodium EDTA, Fragrance, Glyceryl Stearate, Imidazolidinyl Uraea, Isopropyl Palmitate, Lecithine, PEG-100 Stearate, Phenoxy ethanol, Potassium Sorbitate, Tocopheryl Acetate, Vanillyl Butyl Ethar, Water, Xanthan Gum. 

Section 51945-4 (51945-4)

Distributed by:

Flex Power Inc.

Berkeley, CA 94710

Section 55105-1 (55105-1)

Purpose:

Topical Analgesic

Section 55106-9 (55106-9)

Active Ingredients:

Trolamine Salicylate - 10%


Advanced Ingredient Data


Raw Label Data

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