Label: PAIN RELIEF CREAM- trolamine salicylate cream
- NDC Code(s): 62742-4091-1
- Packager: ALLURE LABS INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated November 27, 2017
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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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.
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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
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INGREDIENTS AND APPEARANCE
PAIN RELIEF CREAM
trolamine salicylate creamProduct 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)
