Label: QUALITY CHOICE COLD THERAPY GEL- menthol gel
- NDC Code(s): 83324-007-04
- Packager: Chain Drug Marketing Association, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 25, 2024
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Warnings
For external use only
Flammable: Keep away from excessive heat or open flame
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 a heating pad or device
- Directions
- Other Info
- Inactive Ingredients
- Uses
- Active ingredient
- Purpose
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
QUALITY CHOICE COLD THERAPY GEL
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83324-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) CARBOMER 940 (UNII: 4Q93RCW27E) BENZYL ALCOHOL (UNII: LKG8494WBH) ISOPROPYL ALCOHOL (UNII: ND2M416302) EDETATE DISODIUM (UNII: 7FLD91C86K) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) WATER (UNII: 059QF0KO0R) DMDM HYDANTOIN (UNII: BYR0546TOW) SODIUM HYDROXIDE (UNII: 55X04QC32I) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83324-007-04 118.2 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 04/01/2023 Labeler - Chain Drug Marketing Association, Inc. (011920774) Establishment Name Address ID/FEI Business Operations Astonea Labs Private Label 878533295 manufacture(83324-007)