Label: ANALGESIC- menthol spray
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Contains inactivated NDC Code(s)
NDC Code(s): 76417-8200-1 - Packager: Ouwee Jones, LLC
- 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 October 26, 2011
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- 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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANALGESIC
menthol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76417-8200 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A) menthol 700 mL in 1 L 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:76417-8200-1 0.118 L in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/26/2011 Labeler - Ouwee Jones, LLC (969347462) Registrant - Safetec of America, Inc. (874965262) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc. 874965262 MANUFACTURE