Label: PAIN RELIEF LIQUID ROLLER- camphor 3.5%, menthol 3.5% liquid
- NDC Code(s): 72562-167-25
- Packager: Tommie Copper, 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 9, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
For external use only. Flammable--Do not use while smoking or near heat or flame. When using this product avoid contact with eyes, do not apply to wounds or damaged skin, and do not bandage tightly. Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Extract, Aminomethyl Propanol, Arnica Montana (Arnica) Flower Extract, Calendula Officinalis (Marigold) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Echinacea Angustifolia (Coneflower) Extract, Ethyhexylglycerin, Eucalyptus Globulus (Eucalyptus) Leaf Oil, FD&C Blue No 1, Glycerin, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Isopropyl Alcohol, Juniperus Communis (Juniper) Fruit Extract, Mentha Piperita (Peppermint) Oil, Phenoxyethanol, Water.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAIN RELIEF LIQUID ROLLER
camphor 3.5%, menthol 3.5% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72562-167 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 3.5 g in 100 g CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 3.5 g in 100 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) EUCALYPTUS OIL (UNII: 2R04ONI662) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) ISOPROPYL ALCOHOL (UNII: ND2M416302) JUNIPER BERRY (UNII: O84B5194RL) ALOE VERA LEAF (UNII: ZY81Z83H0X) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) CUCUMBER (UNII: YY7C30VXJT) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) PEPPERMINT OIL (UNII: AV092KU4JH) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CHAMOMILE (UNII: FGL3685T2X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72562-167-25 70 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/19/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/19/2021 Labeler - Tommie Copper, Inc. (081176569) Registrant - Derma Care Research Labs, LLC (116817470) Establishment Name Address ID/FEI Business Operations Derma Care Research Labs, LLC 116817470 manufacture(72562-167)
