Label: PAIN RELIEVING TOPICAL ANALGESIC- trolamine salicylate 10% cream
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Contains inactivated NDC Code(s)
NDC Code(s): 36800-884-03 - Packager: Top Care
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated June 26, 2018
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- Active ingredient Purpose
- DOSAGE & ADMINISTRATION
- PURPOSE
- INDICATIONS & USAGE
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WarningsFor 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 taking a bath or shower within 1 hour before or after applying • do not bandage tightly or use with a heating pad • avoid contact with eyes or muscous membranes • do not apply to wounds or damaged skin
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAIN RELIEVING TOPICAL ANALGESIC
trolamine salicylate 10% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-884 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 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) Cetyl Alcohol (UNII: 936JST6JCN) Glycerin (UNII: PDC6A3C0OX) Methylparaben (UNII: A2I8C7HI9T) Mineral Oil (UNII: T5L8T28FGP) POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632) Propylparaben (UNII: Z8IX2SC1OH) Stearic Acid (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-884-03 1 in 1 CARTON 08/18/2014 1 89 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/18/2014 Labeler - Top Care (006935977) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(36800-884) , label(36800-884)