PAIN RELIEF CREAM- trolamine salicylate cream 
ALLURE LABS INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

Active Ingredients:

Trolamine Salicylate - 10%

Purpose:

Topical Analgesic

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

For external use only.

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

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.

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.

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. 

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

Distributed by:

Flex Power Inc.

Berkeley, CA 94710Image FlxPower40.jpg

Image FlxPower20.jpg

PAIN RELIEF CREAM 
trolamine salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4091
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) TROLAMINE SALICYLATE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4091-157 g in 1 TUBE; Type 0: Not a Combination Product11/27/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/27/2017
Labeler - ALLURE LABS INC. (926831603)
Registrant - ALLURE LABS INC. (926831603)
Establishment
NameAddressID/FEIBusiness Operations
ALLURE LABS INC.926831603manufacture(62742-4091)

Revised: 11/2017
Document Id: 24e37071-c31b-49b4-90be-9d40ba08f93a
Set id: b3ac69c7-5df7-4f47-a3a7-8461892b4276
Version: 1
Effective Time: 20171127
 
ALLURE LABS INC.