PAIN RELIEF CREAM- trolamine salicylate cream

Pain Relief Cream by

Drug Labeling and Warnings

Pain Relief Cream by is a Otc medication manufactured, distributed, or labeled by ALLURE LABS INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Trolamine Salicylate - 10%

PURPOSE

Purpose:

Topical Analgesic

INDICATIONS & USAGE

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

WARNINGS

For external use only.

ASK DOCTOR

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

WHEN USING

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

STOP USE

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INACTIVE INGREDIENT

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. 

DOSAGE & 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

PRINCIPAL DISPLAY PANEL

Distributed by:

Flex Power Inc.

Berkeley, CA 94710

INGREDIENTS AND APPEARANCE

PAIN RELIEF CREAM 
trolamine salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4091
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ)	TROLAMINE SALICYLATE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DISODIUM ACETYL GLUCOSAMINE PHOSPHATE (UNII: SC89MF712W)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETEARETH-2 (UNII: ATB309OMWW)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
N-(1,3-BIS(HYDROXYMETHYL)-2,5-DIOXO-4-IMIDAZOLIDINYL)-N,N'-BIS(HYDROXYMETHYL)UREA (UNII: N9VX1IBW6K)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
TOCOPHEROL (UNII: R0ZB2556P8)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4091-1	57 g in 1 TUBE; Type 0: Not a Combination Product	11/27/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/27/2017

Labeler - ALLURE LABS INC. (926831603)

Registrant - ALLURE LABS INC. (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
ALLURE LABS INC.		926831603	manufacture(62742-4091)