Label: DENATURED ALCOHOL- ethanol liquid
- NDC Code(s): 74047-003-03, 74047-003-32
- Packager: Shantou Kangjie Daily Chemical Industry 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 July 8, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNING
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DENATURED ALCOHOL
ethanol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74047-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74047-003-32 3780 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/06/2023 2 NDC:74047-003-03 38 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 07/08/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/06/2023 Labeler - Shantou Kangjie Daily Chemical Industry Co.,Ltd (527128712) Registrant - Shantou Kangjie Daily Chemical Industry Co.,Ltd (527128712) Establishment Name Address ID/FEI Business Operations Shantou Kangjie Daily Chemical Industry Co.,Ltd 527128712 manufacture(74047-003)