HAND SANITIZER- ethyl alcohol spray 
Tekkware, Inc. d.b.a. Gloucester Bio

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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Alcohol (Ethyl Alcohol or Ethanol)

Ethyl Alcohol

Hand Sanitizer

OTC Antiseptic Drug Products

Inactive Ingredients

water, glycerin, hydrogen peroxide, fragrance

Uses

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

Keep out of reach of children

If swallowed, get medical help or contact Poison Control Center right away.

Directions

- Place enough product on hands to cover all surfaces. Rub hands together until dry.

- Supervise children under six years of age when using this product to avoid swallowing.

Warnings

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

- Do not use in children less than 2 months of age. Do not use on open skin wounds.

- 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 or rash occur. These may be signs of a serious condition.

473mL NDC: 74128-080-16

GB473

473mL NDC: 74128-080-16

GBDrugFacts16oz

GBDrugfacts16oz

3785mL NDC: 74128-080-01

3785mL NDC: 74128-080-01

GB3785

GBDrugFacts1gal

GBDrugFacts1gal

236mL NDC: 74128-070-08

GB236

236mL NDC: 74128-070-08

118mL NDC: 74128-070-04

GB118

118mL NDC: 74128-070-04

HAND SANITIZER 
ethyl alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74128-070
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
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
LEMON OIL (UNII: I9GRO824LL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74128-070-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:74128-070-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/30/2020
HAND SANITIZER 
ethyl alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74128-080
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
LEMON OIL (UNII: I9GRO824LL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74128-080-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:74128-080-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/30/2020
Labeler - Tekkware, Inc. d.b.a. Gloucester Bio (085078398)
Registrant - Tekkware, Inc. d.b.a. Gloucester Bio (085078398)
Establishment
NameAddressID/FEIBusiness Operations
Tekkware, Inc, d.b.a. Gloucester Bio085078398manufacture(74128-070, 74128-080)

Revised: 6/2020
Document Id: a7dcab72-e6b8-dc35-e053-2995a90a270a
Set id: a22ca66a-44e6-efcc-e053-2995a90a027c
Version: 4
Effective Time: 20200612
 
Tekkware, Inc. d.b.a. Gloucester Bio