Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 75778-006-30, 75778-006-31 - Packager: Audy Global Enterprises 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 October 25, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- KEEP OUT OF REACH OF CHILDREN
- WHEN USING
- STOP USE
- Directions
- Other information
- Inactive ingredients
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Package Label - Principal Display Panel
Package combination of 3 bottles, each bottle contains 45 mL NDC: 75778-006-30
Bottle 1 of 3, Water Melon scent 45 mL NDC: 75778-006-30
Bottle 2 of 3, Citrus scent 45 mL NDC: 75778-006-30
Bottle 3 of 3, Vanilla Cinnamon scent 45 mL NDC: 75778-006-30
Package combination of 3 bottles, each bottle contains 45 mL NDC: 75778-006-31
Bottle 1 of 3, Lavender scent 45 mL NDC: 75778-006-31
Bottle 2 of 3, Mint scent 45 mL NDC: 75778-006-31
Bottle 3 of 3, Aloe Vera scent 45 mL NDC: 75778-006-31
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75778-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 67 mL in 100 mL Inactive Ingredients Ingredient Name Strength LIMONENE, (+)- (UNII: GFD7C86Q1W) ALOE VERA LEAF (UNII: ZY81Z83H0X) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) WATER (UNII: 059QF0KO0R) CITRUS AURANTIFOLIA SEED OIL (UNII: EW089HAI77) LEMON OIL, TERPENELESS (UNII: X69W83NI7V) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERETH-26 (UNII: NNE56F2N14) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) CITRAL (UNII: T7EU0O9VPP) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) LINALOOL, (+/-)- (UNII: D81QY6I88E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75778-006-30 1 in 1 PACKAGE, COMBINATION 10/25/2021 1 3 in 1 PACKAGE 1 45 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:75778-006-31 1 in 1 PACKAGE, COMBINATION 10/25/2021 2 3 in 1 PACKAGE 2 45 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/14/2021 Labeler - Audy Global Enterprises Inc. (079171473) Establishment Name Address ID/FEI Business Operations Zhongrong Technology Corporation Ltd. 529575698 manufacture(75778-006)