Label: ANTI-BACTERIAL HAND CLEANSER- ethyl alcohol liquid
- NDC Code(s): 49852-301-30, 49852-301-45
- Packager: Tri-Coastal Design Company Inc.
- 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 January 1, 2018
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- Active Ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
- Other information
- Inactive Ingredients
- Package Label
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INGREDIENTS AND APPEARANCE
ANTI-BACTERIAL HAND CLEANSER
ethyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49852-301 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) TROLAMINE (UNII: 9O3K93S3TK) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W) FD&C RED NO. 4 (UNII: X3W0AM1JLX) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49852-301-30 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/2014 2 NDC:49852-301-45 45 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/01/2014 Labeler - Tri-Coastal Design Company Inc. (609734900) Establishment Name Address ID/FEI Business Operations Ganzhou Olivee Cosmetic Co., Ltd. 543008195 manufacture(49852-301)