Label: PERFORM COOL AND SOOTHING PAIN RELIEVING- menthol gel
- NDC Code(s): 59316-111-10, 59316-111-11, 59316-111-20
- Packager: RB Health (US) LLC
- 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 February 8, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Uses
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Warnings
For external use only.
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, Arnica Montana Flower Extract, Blue 1, Camellia Sinensis Leaf Extract, Carbomer, Citrus Aurantifolia (Lime) Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Eucalyptus Globulus Leaf Oil, Glycerin, Hypericum Perforatum Oil, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Lavandula Hybrida Oil, Mentha Piperita (Peppermint) Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Pinus Sylvestris Leaf Oil, Polysorbate 20, Silica, Thymus Vulgaris (Thyme) Flower/Leaf Oil, Triethanolamine, Water
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 118 mL Tube Label
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INGREDIENTS AND APPEARANCE
PERFORM COOL AND SOOTHING PAIN RELIEVING
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59316-111 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 35 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GREEN TEA LEAF (UNII: W2ZU1RY8B0) LIME OIL, COLD PRESSED (UNII: UZH29XGA8G) ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B) EUCALYPTUS OIL (UNII: 2R04ONI662) GLYCERIN (UNII: PDC6A3C0OX) HYPERICUM OIL (UNII: OZU2FC70HY) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) ISOPROPYL ALCOHOL (UNII: ND2M416302) LAVANDIN OIL (UNII: 9RES347CKG) PEPPERMINT OIL (UNII: AV092KU4JH) NUTMEG OIL (UNII: Z1CLM48948) PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) POLYSORBATE 20 (UNII: 7T1F30V5YH) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) THYME OIL (UNII: 2UK410MY6B) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59316-111-20 1 in 1 CARTON 05/18/2015 1 118 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:59316-111-10 3 mL in 1 TUBE; Type 0: Not a Combination Product 05/18/2015 12/31/2023 3 NDC:59316-111-11 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/18/2015 12/31/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/18/2015 Labeler - RB Health (US) LLC (081049410)