HAND SANITIZER- alcohol gel 
Global Exports U.S.A., Inc.

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Active Ingredient

Alcohol 70% v/v

Purpose

Antiseptic

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

in children less than 2 months of age. on open skin wounds

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

Other information

Inactive ingredients

Aloe Vera, Carbomer Interpolymer (type B), Glycerin, Lemon oil, Triethanolamine, Water (Aqua)

Package Label - Principal Display Panel

image of bottle label

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77050-016
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Lemon Oil (UNII: I9GRO824LL)  
Glycerin (UNII: PDC6A3C0OX)  
Trolamine (UNII: 9O3K93S3TK)  
Water (UNII: 059QF0KO0R)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Carbomer Interpolymer Type B (Allyl Pentaerythritol Crosslinked) (UNII: 132584PQMO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77050-016-01473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/04/2020
2NDC:77050-016-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2020
3NDC:77050-016-03118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2020
4NDC:77050-016-04237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/01/2020
5NDC:77050-016-05946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/01/2020
6NDC:77050-016-061893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2020
7NDC:77050-016-071893 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/01/2020
8NDC:77050-016-083785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2020
9NDC:77050-016-093785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/01/2020
10NDC:77050-016-1018927 mL in 1 CONTAINER; Type 0: Not a Combination Product07/01/2020
11NDC:77050-016-1118927 mL in 1 CONTAINER; Type 0: Not a Combination Product07/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)06/04/2020
Labeler - Global Exports U.S.A., Inc. (607803517)
Establishment
NameAddressID/FEIBusiness Operations
Global Exports U.S.A., Inc.607803517PACK(77050-016) , LABEL(77050-016)

Revised: 1/2024
Document Id: adbc3c1c-a3d2-4560-a29f-8d28fb1e147d
Set id: a73b51d2-9bc4-74ce-e053-2a95a90a0445
Version: 3
Effective Time: 20240124
 
Global Exports U.S.A., Inc.