Label: DUANE READE HOT AND COLD BALM- methyl salicylate and menthol salve
- 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.
Updated February 28, 2011
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- Active Ingredients Purpose
- Allergy alert:
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions adults and children over 12 years:
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
DUANE READE HOT AND COLD BALM
methyl salicylate and menthol salve
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24488-023 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE 30.16 mL in 104 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 7.90 mL in 104 mL Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) PARAFFIN (UNII: I9O0E3H2ZE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24488-023-02 104 mL in 1 CANISTER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/28/2011 Labeler - Duane Reade (961956229) Registrant - Creations Garden Natural Products Inc. (961956229) Establishment Name Address ID/FEI Business Operations Creations Garden Natural Products Inc. 961956229 manufacture