Label: THERAPEUTIC ICY COLD COOLING PAIN RELIEF ROLL-ON- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 69851-101-13 - Packager: APEX-CAREX HEATHCARE PRODUCTS
- 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 November 23, 2019
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USES
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WARNINGS
FOR EXTERNAL USE ONLY.
DO NOT USE NEAR EYES, MOUTH, MUCUS MEMBRANES, CUTS, RASHES AND SORES. IF CONTACT OCCURS, FLUSH WITH COLD WATER.
DO NOT USE WITH HEATING PAD OR DEVICE, OR UNDER BANDAGES.
DO NOT USE IF PREGNANT OR BREASTFEEDING. PLEASE CONSULT YOUR PHYSICIAN PRIOR TO USE.
DO NOT APPLY TO WOUNDS OR DAMAGED SKIN.
STOP USE AND ASK A DOCTOR IF IRRITATION PERSISTS.
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
THERAPEUTIC ICY COLD COOLING PAIN RELIEF ROLL-ON
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69851-101 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) ALCOHOL (UNII: 3K9958V90M) 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:69851-101-13 88.8 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 05/15/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/15/2015 Labeler - APEX-CAREX HEATHCARE PRODUCTS (622368947)