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
- 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.
Updated March 13, 2020
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- Drug Facts
- Active Ingredient
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.
- Keep out of reach of children.
- Other information
- Inactive ingredients
SPL UNCLASSIFIED SECTION
Compare to the active ingredient in Icy Hot® Patch
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.
Universal Distribution Center
96 Distribution Boulevard • Edison, NJ 08817
INGREDIENTS AND APPEARANCE
COLD AND HOT MEDICATED PATCH
Product 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) KAOLIN (UNII: 24H4NWX5CO) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) ALCOHOL (UNII: 3K9958V90M) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TARTARIC ACID (UNII: W4888I119H) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) 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 not final part348 06/21/2017 Labeler - Universal Distribution Center LLC (019180459) Registrant - Universal Distribution Center LLC (019180459) Establishment Name Address ID/FEI Business Operations Zhejiang Dingtai Pharmaceutical Co., Ltd 420598724 manufacture(52000-032)