Label: COOLING- menthol gel
- NDC Code(s): 82551-119-14
- Packager: FULL EIGHT LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 30, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USE
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WARNINGS
For external use only
Flammable: Keep away from excessive heat and open flame
Ask a doctor before use if you have: Sensitive skin
When using this product: Avoid contact with eyes or mucous membranes- Do not apply to wounds or damaged skin
- Do not use with other ointments, creams, sprays, or liniments
- Do not apply to irritated skin or if excessive irritation develops
- Do not bandage
- Wash hands after use with cool water
- Do not use with heating pad or device
Stop use and ask a doctor if: Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur
If pregnant or breast-feeding: Ask a doctor before use - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COOLING
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82551-119 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1.2 g in 100 mL Inactive Ingredients Ingredient Name Strength CAMPHOR OIL (UNII: 75IZZ8Y727) TROLAMINE (UNII: 9O3K93S3TK) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) DMDM HYDANTOIN (UNII: BYR0546TOW) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) OLIVE OIL (UNII: 6UYK2W1W1E) EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6) GLYCERIN (UNII: PDC6A3C0OX) SPEARMINT OIL (UNII: C3M81465G5) EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW) EUCALYPTUS OIL (UNII: 2R04ONI662) PEPPERMINT OIL (UNII: AV092KU4JH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82551-119-14 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/26/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 01/26/2022 Labeler - FULL EIGHT LLC (096786623)