Label: CVS HEALTH COLD AND HOT ROLL-ON MENTHOL- menthol, unspecified form liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 66902-241-25 - Packager: NATURAL ESSENTIALS, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 January 17, 2019
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient:
- Purpose:
- Uses:
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Warnings:
For external use only.
When using this product
- use only as directed. Read and follow all directions and warnings on this label.
- rare cases of serious burns have been reported with products of this type
- do not bandage tightly or apply local heat (such as heating pads) or medicated patch to the area of use
- avoid contact with eyes or mucous membranes
- do not apply to wounds or damaged, broken or irritated skin
- a transient burning sensation may occur upon application but generally disappears in several days
- if severe burning sensation occurs, discontinue use immediately
- do not expose the area treated with product to heat or direct sunlight
- avoid applying into skin folds.
- Directions: adults and children over 12 years:
- Other information:
- Inactive Ingredients
- Principal Display Panel - Cold & Hot Roll-On Menthol 16% Box Label
- Principal Display Panel - Cold & Hot Roll-On Menthol 16% Container Label
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INGREDIENTS AND APPEARANCE
CVS HEALTH COLD AND HOT ROLL-ON MENTHOL
menthol, unspecified form liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66902-241 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 160 mg in 1 mL Inactive Ingredients Ingredient Name Strength CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) CAPSAICIN (UNII: S07O44R1ZM) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66902-241-25 1 in 1 BOX 01/17/2018 1 73 mL in 1 CONTAINER; 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 01/17/2018 Labeler - NATURAL ESSENTIALS, INC. (947484713) Establishment Name Address ID/FEI Business Operations NATURAL ESSENTIALS, INC. 947484713 MANUFACTURE(66902-241)