Label: ETHYL ALCOHOL gel
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Contains inactivated NDC Code(s)
NDC Code(s): 49283-700-32 - Packager: Chemco Corporation
- 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 June 2, 2020
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- DOSAGE & ADMINISTRATION
- WARNINGS
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
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- PURPOSE
- ACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
ETHYL ALCOHOL
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49283-700 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.1 mL in 100 mL POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.45 mL in 100 mL ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.05 mL in 100 mL WATER (UNII: 059QF0KO0R) 1 mL in 100 mL BENZYL SALICYLATE (UNII: WAO5MNK9TU) 0.01 mL in 100 mL BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) 0.01 mL in 100 mL LINALOOL, (+)- (UNII: F4VNO44C09) 0.01 mL in 100 mL CARBOMER 940 (UNII: 4Q93RCW27E) 0.35 mL in 100 mL ISOPROPYL ALCOHOL (UNII: ND2M416302) 0.1 mL in 100 mL Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49283-700-32 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/02/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/02/2020 Labeler - Chemco Corporation (032495954) Registrant - Chemco Corporation (032495954) Establishment Name Address ID/FEI Business Operations Chemco Corporation 032495954 manufacture(49283-700)