Label: FROZEN BLUEBERRY SCENTED HAND SANITIZER 01- chloroxylenol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 76383-064-01 - Packager: BBC GROUP LIMITED
- 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 13, 2020
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INGREDIENTS AND APPEARANCE
FROZEN BLUEBERRY SCENTED HAND SANITIZER 01
chloroxylenol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76383-064 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 0.015 g in 100 mL Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.0002 g in 100 mL HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) 0.3 mL in 100 mL POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) 0.3 mL in 100 mL BLUEBERRY (UNII: 253RUG1X1A) 0.05 mL in 100 mL WATER (UNII: 059QF0KO0R) 92.1996 mL in 100 mL CARBOMER 934 (UNII: Z135WT9208) 0.09 mL in 100 mL PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 6.5 mL in 100 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.5 mL in 100 mL AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.045 mL in 100 mL Product Characteristics Color blue Score Shape Size Flavor BLUEBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76383-064-01 59 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package 05/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/15/2020 Labeler - BBC GROUP LIMITED (421270060) Registrant - Townley Inc. (016956158) Establishment Name Address ID/FEI Business Operations BBC GROUP LIMITED 421270060 manufacture(76383-064)
