Label: PAINFIX RELIEF- menthol gel
- NDC Code(s): 72749-001-00, 72749-001-03
- Packager: PainFix LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 28, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose
- Uses
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Warnings
Avoid direct contact with eyes.
For external use only.When using this product • use only as directed • avoid contact with eyes or mucous membranes • do not apply local heat to the area of use • do not apply to wounds, broken, damaged or irritated skin
Stop use and ask a doctor if • condition worsens or symptoms persist for more than 7 days • skin irritation develops or you experience signs of skin injury, such as pain, swelling, or blistering where product is applied
If pregnant or breast-feeding, ask a health professional before use.
- Directions
- Other Information
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Ingredients
Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Bambusa Vulgaris (Mastic) Sap Extract, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Cinnamomum Cassia Oil, Citrus Aurantium Dulcis (Orange) Extract, Commiphora Myrrha (Myrrh) Extract, Curcuma Longa (Turmeric) Extract, Glycerin, Glyceryl Laurate, Glyceryl Undecylenate, Ilex Paraguariensis (Yerba Mate) Extract, Magnesium Sulfate, MethylSulfonylmethane (MSM), Polysorbate-20, Propylene Glycol, Rheum Palmatum (Rhubarb) Extract, Scutellaria Baicalensis (Skullcap) Extract, Sesamum Indicum (Sesame) Oil, Sodium Hydroxide, Sorbic Acid, Xanthan Gum, Zingiber Officinale (Ginger) Extract
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
PAINFIX RELIEF
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72749-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 50 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) BAMBUSA VULGARIS SAP (UNII: 26W4035XBO) SHEA BUTTER (UNII: K49155WL9Y) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL ALCOHOL (UNII: 936JST6JCN) CHINESE CINNAMON OIL (UNII: A4WO0626T5) ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B) MYRRH (UNII: JC71GJ1F3L) TURMERIC (UNII: 856YO1Z64F) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL LAURATE (UNII: Y98611C087) GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) RHUBARB (UNII: G280W4MW6E) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) SESAME OIL (UNII: QX10HYY4QV) SODIUM HYDROXIDE (UNII: 55X04QC32I) SORBIC ACID (UNII: X045WJ989B) XANTHAN GUM (UNII: TTV12P4NEE) GINGER (UNII: C5529G5JPQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72749-001-00 1 in 1 BOX 02/01/2019 11/30/2022 1 60 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:72749-001-03 57 g in 1 BOTTLE; Type 0: Not a Combination Product 12/28/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 02/01/2019 Labeler - PainFix LLC (116908667)