Label: KINKAN COOL- diphenhydramine hydrochloride, menthol liniment
- NDC Code(s): 51027-0330-2
- Packager: KINKANDO CO., LTD .
- 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 December 30, 2022
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INGREDIENTS AND APPEARANCE
KINKAN COOL
diphenhydramine hydrochloride, menthol linimentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51027-0330 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 1 g in 50 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.5 g in 50 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51027-0330-2 96 in 1 CARTON 04/26/2000 1 1 in 1 BOX 1 50 mL in 1 BOTTLE; 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 04/26/2000 Labeler - KINKANDO CO., LTD . (694329470) Establishment Name Address ID/FEI Business Operations KINKANDO CO., LTD . 715451980 manufacture(51027-0330)