Label: ANALGESIC- menthol gel
- NDC Code(s): 61010-8202-0
- Packager: Safetec of America, Inc.
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated October 1, 2018
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- Official Label (Printer Friendly)
- 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 control 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
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INGREDIENTS AND APPEARANCE
ANALGESIC
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61010-8202 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A) menthol 70 mg 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) xanthan gum (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61010-8202-0 0.088 L in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 09/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/01/2018 Labeler - Safetec of America, Inc. (874965262) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc 874965262 MANUFACTURE(61010-8202)