Label: BERKLEY JENSEN INSTANT SANITIZER- ethyl alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 68391-167-03, 68391-167-13 - Packager: BJWC
- 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 31, 2017
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INGREDIENTS AND APPEARANCE
BERKLEY JENSEN INSTANT SANITIZER
ethyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68391-167 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 650 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOPROPYL ALCOHOL (UNII: ND2M416302) GLYCERIN (UNII: PDC6A3C0OX) CARBOMER 934 (UNII: Z135WT9208) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68391-167-03 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/27/2017 2 NDC:68391-167-13 354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/27/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/27/2017 Labeler - BJWC (159082692) Registrant - Apollo Health and Beauty Care Inc. (201901209) Establishment Name Address ID/FEI Business Operations Apollo Health and Beauty Care Inc. 201901209 manufacture(68391-167)