Label: PREMIERES PAIN- menthol spray
- NDC Code(s): 32472-102-03
- 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 January 12, 2011
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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:
- 1-800-576-7616 Amazing-Solutions.com
- 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) xanthan gum (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:32472-102-03 88 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/12/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/12/2011 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)