Label: CVS PAIN RELIEVING- camphor 5.5% menthol 16% lotion
- NDC Code(s): 51316-885-16
- Packager: CVS
- 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 December 19, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
For extranal use only
avoid contact with eyes and mucous membranes
do not bandage tightly
do not use with a heating pad, medicated patch or other of local heat
do not apply to wounds or damaged, broken or irritated skin
- DOSAGE & ADMINISTRATION
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INGREDIENTS AND APPEARANCE
CVS PAIN RELIEVING
camphor 5.5% menthol 16% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51316-885 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 16 mg in 1 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5.5 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 80 (UNII: 6OZP39ZG8H) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) PENTYLENE GLYCOL (UNII: 50C1307PZG) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEPPERMINT OIL (UNII: AV092KU4JH) CLOVE OIL (UNII: 578389D6D0) ALCOHOL (UNII: 3K9958V90M) EUCALYPTUS OIL (UNII: 2R04ONI662) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51316-885-16 72 g in 1 TUBE; Type 0: Not a Combination Product 12/19/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/19/2022 Labeler - CVS (062312574)