Label: ONEBACK- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 69643-101-11 - Packager: WORLD WIDE MEDICAL SERVICES, INC.
- 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 April 30, 2015
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ONEBACK
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69643-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 3.9 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOPROPYL ALCOHOL (UNII: ND2M416302) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) CARBOMER 940 (UNII: 4Q93RCW27E) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) HYDRATED SILICA (UNII: Y6O7T4G8P9) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) METHYLPARABEN (UNII: A2I8C7HI9T) UNCARIA TOMENTOSA LEAF (UNII: 487U8M3D2P) BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K) CAMPHOR OIL (UNII: 75IZZ8Y727) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69643-101-11 88.8 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/03/2015 Labeler - WORLD WIDE MEDICAL SERVICES, INC. (101816366)