Label: PREMIERES PAIN- menthol spray
- NDC Code(s): 32472-102-01
- Packager: Premiere Enterprises
- 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 October 22, 2015
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- Active Ingredients
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- Uses:
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- Other Information:
- Inactive Ingredients:
- Principal Display Panel - Bottle Label
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INGREDIENTS AND APPEARANCE
PREMIERES PAIN
menthol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:32472-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A) menthol 7 g in 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) isopropyl alcohol (UNII: ND2M416302) glycerin (UNII: PDC6A3C0OX) eucalyptus oil (UNII: 2R04ONI662) methyl salicylate (UNII: LAV5U5022Y) peppermint oil (UNII: AV092KU4JH) coconut oil (UNII: Q9L0O73W7L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:32472-102-01 29.5 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/07/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/07/2011 Labeler - Premiere Enterprises (556225498) Registrant - Safetec of America, Inc. (874965262) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc. 874965262 MANUFACTURE(32472-102)