HAND SANITIZER- alcohol gel 
Audy Global Enterprises Inc.

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.

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Simply Natural Hand Sanitizer

Active Ingredient(s)

Ethyl Alcohol 67%

Purpose

Antiseptic

Use

For handwashing to decrease bacteria on the skin. Recommended for repeated use.

Warnings

For external use only. Flammable. Keep away from heat or flame.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor If irritation redness develop.

If condition persists for more than 72 hours.

Directions

Other information

from excessive heat and direct sun.

Inactive ingredients

Water, Aloe Barbadensis Leaf Juice, Radish Root Ferment Filtrate, Fragrance (parfum), Glycereth-26, Lime (Citrus Aurantifolia) Seed Oil, Lemon (Citrus Limon) Peel Oil, FD&C Red No. 40, FD&C Yellow No. 5, Limonene, Citral, Citronellol, Linalool

Package Label - Principal Display Panel

Package combination of 3 bottles, each bottle contains 45 mL NDC: 75778-006-30 75778-006-01_3-bottle combination package_45 mL

Bottle 1 of 3, Water Melon scent 45 mL NDC: 75778-006-30 75778-006-01_Water Melon scent bottle 45 mL

Bottle 2 of 3, Citrus scent 45 mL NDC: 75778-006-30 75778-006-01_Citrus scent bottle 45 mL

Bottle 3 of 3, Vanilla Cinnamon scent 45 mL NDC: 75778-006-30 75778-006-01_Vanilla Cinnamon scent bottle 45 mL

Package combination of 3 bottles, each bottle contains 45 mL NDC: 75778-006-31 75778-006-02_3-bottle combination package_45 mL

Bottle 1 of 3, Lavender scent 45 mL NDC: 75778-006-31 75778-006-02_Lavender scent bottle 45 mL

Bottle 2 of 3, Mint scent 45 mL NDC: 75778-006-31 75778-006-02_Mint scent bottle 45 mL

Bottle 3 of 3, Aloe Vera scent 45 mL NDC: 75778-006-31 75778-006-31_Aloe Vera scent bottle 45 mL

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75778-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL67 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75778-006-301 in 1 PACKAGE, COMBINATION10/25/2021
13 in 1 PACKAGE
145 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:75778-006-311 in 1 PACKAGE, COMBINATION10/25/2021
23 in 1 PACKAGE
245 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/14/2021
Labeler - Audy Global Enterprises Inc. (079171473)
Establishment
NameAddressID/FEIBusiness Operations
Zhongrong Technology Corporation Ltd.529575698manufacture(75778-006)

Revised: 10/2021
Document Id: cf336778-6cfe-5fbc-e053-2995a90ad277
Set id: c24d7bef-39c2-6dae-e053-2995a90a297f
Version: 2
Effective Time: 20211025
 
Audy Global Enterprises Inc.