Label: ANALGESIC- menthol spray
- NDC Code(s): 61010-8200-1
- Packager: Safetec of America, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated March 2, 2024
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses:
-
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
-
INGREDIENTS AND APPEARANCE
ANALGESIC
menthol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61010-8200 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 70 mg 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:61010-8200-1 118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 10/26/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 10/26/2011 Labeler - Safetec of America, Inc. (874965262) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc. 874965262 manufacture(61010-8200)