Label: PAIN RELIVING ROLL-ON- menthol gel
- NDC Code(s): 67510-0673-2
- Packager: KAREWAY PRODUCT, 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 24, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only.
Flammable: Keep away from excessive heat or open flame
When using this product
- use only as directed
- avoid contact with the eyes or on mucous membranes
- do not apply to wounds or damaged skin
- do not apply to irritated skin or if excessive irritation develops
- do not bandage tightly or use with heating pad or device
Stop use and ask a doctor if
- you experience pain, swelling or blistering of the skin
- condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
- arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age
- Directions
- Other information
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Inactive ingredients
Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis (Green Tea) Leaf Extract, Camphor, Carbomer, Centella Asiatica Extract, Ethylhexylglycerin, FD&C Blue No.1, FD&C Yellow No.5, IIex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Phenoxyethanol, Propylene Glycol, Tocopheryl Acetate, Trolamine, Water
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAIN RELIVING ROLL-ON
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0673 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 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) CAMPHOR OIL (UNII: 75IZZ8Y727) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CARBOMER 940 (UNII: 4Q93RCW27E) CENTELLA ASIATICA (UNII: 7M867G6T1U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ISOPROPYL ALCOHOL (UNII: ND2M416302) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67510-0673-2 74 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 01/24/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/24/2023 Labeler - KAREWAY PRODUCT, INC. (121840057)