Label: PREMIERES PAIN- menthol spray
- NDC Code(s): 32472-102-04
- Packager: Premiere Enterprises
- 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 June 17, 2015
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses:
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Warnings:
- For external use only
- Flammable. Keep away from flame.
- Keep out of reach of children- if swallowed get medical help or contact a poison center right away.
- Avoid contact with eyes
- Do not apply to open wounds or damaged skin
- Do not bandage tightly
- Consult a doctor if excessive skin irritation occurs, or if you are prone to allergic reactions to salicylates, including aspirin. If condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, discontinue use of this product and consult a doctor.
- Directions:
- Other Information:
- Inactive Ingredients:
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL
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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 .07 g in 1 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:32472-102-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/28/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/28/2010 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)