Label: COLD AND HOT PAIM RELIEVING CAREONE- menthol 16.00% liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 41520-777-03 - Packager: CareOne
- 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 9, 2018
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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 • do not
bandage tightly or use with a heating pad • avoid contact with
eyes and mucous membranes • do not apply to wounds or
damaged, broken or irritated skin • if you experience pain,
swelling, or blistering of the skin where an OTC topical muscle
and joint pain reliever was applied, stop using the product and
seek medical attention immediately. These products should not
cause pain or skin damage.
Stop use and ask doctor if • condition worsens • redness is
present • irritation develops • symptoms persist for more than 7
days or clear up and occur again within a few days
Flammable • keep away from fire or flame - Keep out of reach of children.
- Directions
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COLD AND HOT PAIM RELIEVING CAREONE
menthol 16.00% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-777 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 16 g in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) Capsaicin (UNII: S07O44R1ZM) Glycerin (UNII: PDC6A3C0OX) Isopropyl Myristate (UNII: 0RE8K4LNJS) Propylene Glycol (UNII: 6DC9Q167V3) ALCOHOL (UNII: 3K9958V90M) TROLAMINE (UNII: 9O3K93S3TK) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41520-777-03 1 in 1 CARTON 07/14/2015 1 73 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 07/14/2015 Labeler - CareOne (809183973) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(41520-777) , label(41520-777)