Label: KT RECOVERY PLUS PAIN RELIEF GEL- camphor, menthol gel
- NDC Code(s): 73044-103-01, 73044-103-02
- Packager: KT Health 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 March 21, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- Uses
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Warnings
• For external use only
• Do not apply to wounds or damaged skin
• Do not bandage tightly • Avoid contact with eyes
• Keep out of reach of children
• If swallowed, get medical help or contact a Poison Control Center immediately
• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician
• If pregnant or breast feeding, ask a health professional before use - KEEP OUT OF REACH OF CHILDREN
- Directions
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INACTIVE INGREDIENT
Water, Alcohol, Glycerin, Tocopheryl Acetate, ButyrospermumParkii (Shae Butter) Extract, Arnica Montana Flower Extract, Hamamelis Virginiana (Witch Hazel) Extract, Ammonium Acryloyldimethyltaurate/VP Copolymer, Euphorbia Cerifera (Candelilla) Wax, Sodium Starch Octenylsuccinate,
Bio-Saccharide Gum-1, Phenoxyethanol, Hydrated Silica, Ethylhexylglycerin - Product label
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INGREDIENTS AND APPEARANCE
KT RECOVERY PLUS PAIN RELIEF GEL
camphor, menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73044-103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5 g in 100 mL CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SHEANUT (UNII: 84H6HBP32L) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) CANDELILLA WAX (UNII: WL0328HX19) OCTENYLSUCCINIC ACID (UNII: 12UZE4X73L) BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) PHENOXYETHANOL (UNII: HIE492ZZ3T) HYDRATED SILICA (UNII: Y6O7T4G8P9) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73044-103-01 100 mL in 1 TUBE; Type 0: Not a Combination Product 04/15/2023 2 NDC:73044-103-02 1 in 1 BOX 04/15/2023 2 89 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/15/2023 Labeler - KT Health LLC (807008037) Establishment Name Address ID/FEI Business Operations Adonis Inc 116983147 manufacture(73044-103)
