Label: PAIN RELIEF COLD THERAPY GEL 3 FL OZ- menthol 4% gel gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 72351-641-03 - Packager: SOTAC PHARMACEUTICAL PRIVATE LIMITED
- Category: HUMAN OTC DRUG LABEL
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 December 31, 2022
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
-
Warnings
For external use only
When using this product
• avoid contact with the eyes or mucous membranes
• do not apply to wounds or damaged skin
• do not use with other ointments, creams, sprays or liniments
• do not apply to irritated skin or if excessive irritation develops
• do not bandage
• wash hands after use with cool water
• do not use with heating pad or device
- Directions
- Other Information
-
Inactive ingredients
aloe vera gel, arnica montana flower extract, articum lappa root (burdock) extract, boswellia carterii resin extract, calendula officinalis extract, camellia sinensis (green tea) leaf extract, camphor, carbomer 934, colloidal silicon dioxide, FD&C blue no.1, FD&C yellow no.5, glycerin, ilex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, melissa officinalis (lemon balm) leaf extract, purified water, sorbic acid, tocopheryl acetate, triethanolamine
- Questions or comments
- Pain Relief Cold Therapy Gel 3 FL OZ
-
INGREDIENTS AND APPEARANCE
PAIN RELIEF COLD THERAPY GEL 3 FL OZ
menthol 4% gel gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72351-641 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) ISOPROPYL ALCOHOL (UNII: ND2M416302) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) CAMPHOR (NATURAL) (UNII: N20HL7Q941) CARBOMER 934 (UNII: Z135WT9208) GLYCERIN (UNII: PDC6A3C0OX) FRANKINCENSE (UNII: R9XLF1R1WM) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) GREEN TEA LEAF (UNII: W2ZU1RY8B0) TROLAMINE (UNII: 9O3K93S3TK) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) BRILLIANT BLUE G (UNII: M1ZRX790SI) MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) ALOE VERA LEAF (UNII: ZY81Z83H0X) SORBIC ACID (UNII: X045WJ989B) Product Characteristics Color green Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72351-641-03 88.72 mL in 1 TUBE; Type 0: Not a Combination Product 04/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/01/2021 Labeler - SOTAC PHARMACEUTICAL PRIVATE LIMITED (876894019) Establishment Name Address ID/FEI Business Operations Sotac Pharmaceutical Private limited 876894019 label(72351-641) , analysis(72351-641) , manufacture(72351-641)