Label: COLD AND HOT MEDICATED PATCH- menthol patch
- NDC Code(s): 52000-032-42
- Packager: Universal Distribution Center LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 4, 2024
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
- Purpose
- Uses
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WARNINGS
For external use only.
When using this product • use only as directed • do not bandage tightly or use with a heating pad
• avoid contact with eyes and mucous membranes • do not apply to wounds or damaged skin.Stop use and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • skin irritation develops.
If pregnant or breast-feeding, ask a health professional before use.
- Directions
- Other information
- Inactive ingredients
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SPL UNCLASSIFIED SECTION
Compare to the active ingredient in Icy Hot® Patch
EXTRA STRENGTH
Contains Menthol 5%
Works on contact for cooling pain relief
Pain relieving ointment on a breathable adhesive pad
*This product is not manufactured or distributed by Chattem Inc., owner of the registered trademark Icy Hot® Patch.
Distributed by:
Universal Distribution Center
96 Distribution Boulevard • Edison, NJ 08817
Made in P.R.C.
- Packaging
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INGREDIENTS AND APPEARANCE
COLD AND HOT MEDICATED PATCH
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52000-032 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 205.5 mg Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) EDETATE DISODIUM (UNII: 7FLD91C86K) KAOLIN (UNII: 24H4NWX5CO) CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) WATER (UNII: 059QF0KO0R) TARTARIC ACID (UNII: W4888I119H) POVIDONE K90 (UNII: RDH86HJV5Z) DMDM HYDANTOIN (UNII: BYR0546TOW) ALCOHOL 95% (UNII: 7528N5H79B) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52000-032-42 1 in 1 BOX 06/21/2017 1 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 06/21/2017 Labeler - Universal Distribution Center LLC (019180459) Registrant - Universal Distribution Center LLC (019180459) Establishment Name Address ID/FEI Business Operations Koolcare Technology Co., Ltd. 602479389 manufacture(52000-032)