Label: REAL TIME PAIN RELIEF THERAPEUTIC HAND CREAM- trolamine salicylate 10% lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58133-400-04, 58133-400-12, 58133-400-15 - Packager: Cosmetic Specialty Labs, Inc.
- Category: HUMAN OTC DRUG LABEL
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 January 3, 2018
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- Active ingredient Purpose
- Purpose
- Uses
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Warnings
For external use only
Allergy alert: if prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
When using this product • use only as directed • avoid contact with eyes or muscous membranes • do not apply to wounds or damaged skin
- Directions
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Inactive ingredients:
Aloe Barbadensis Leaf, Arnica Montana Flower Extract, Butylene Glycol, Butyrospermum Parkii (Shea Butter), C13-14 Isoparaffin, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Cetyl Alcohol, Emu Oil, Fragrance, Laureth-7, Methylsulfonylmethane, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Polyacrylamide, Purified Water, Salix Alba (Willow) Bark Extract, Tocopheryl Acetate, Triethanolamine.
- Package Label and Principal Display Panel
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INGREDIENTS AND APPEARANCE
REAL TIME PAIN RELIEF THERAPEUTIC HAND CREAM
trolamine salicylate 10% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58133-400 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) TROLAMINE SALICYLATE 10 g in 100 mL Inactive Ingredients Ingredient Name Strength DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) EMU OIL (UNII: 344821WD61) LAURETH-7 (UNII: Z95S6G8201) BUTYROSPERMOL (UNII: 6SF0L0FL42) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CARBOMER 940 (UNII: 4Q93RCW27E) ALOE VERA LEAF (UNII: ZY81Z83H0X) CETYL ALCOHOL (UNII: 936JST6JCN) PROPYLPARABEN (UNII: Z8IX2SC1OH) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J) 2-(2-(2-(2-PHENOXYETHOXY)ETHOXY)ETHOXY)ETHANOL (UNII: Y050HYR4XA) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) SALIX ALBA BARK (UNII: 205MXS71H7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58133-400-15 45 mL in 1 TUBE; Type 0: Not a Combination Product 12/16/2014 2 NDC:58133-400-04 120 mL in 1 TUBE; Type 0: Not a Combination Product 12/16/2014 3 NDC:58133-400-12 345 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 12/16/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/16/2014 Labeler - Cosmetic Specialty Labs, Inc. (032973000) Registrant - Cosmetic Specialty Labs, Inc. (032973000) Establishment Name Address ID/FEI Business Operations Cosmetic Specialty Labs, Inc. 032973000 manufacture(58133-400)