HAND SANITIZER- ethyl alcohol 70% gel 
Premium Printing 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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Premium Gel Hand Sanitizer

Active Ingredient

Ethyl Alcohol 70%

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

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 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 immediately.

­­­­­­­­­­­­­­­­­­­­­Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Carbopol, Glycerin, Triethanolamine

Gel Hand Sanitizer

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HAND SANITIZER 
ethyl alcohol 70% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78635-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL175 mL  in 250 mL
Inactive Ingredients
Ingredient NameStrength
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
TRIETHANOLAMINE ISOSTEARATE (UNII: T8OTU5ECY5)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78635-100-08250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
2NDC:78635-100-331000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
3NDC:78635-100-044000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2020
Labeler - Premium Printing Inc. (035632750)
Registrant - Premium Printing Inc. (035632750)

Revised: 6/2020
Document Id: a8fe8dd8-a2b1-9002-e053-2995a90a51aa
Set id: a8fe89e5-0240-7b99-e053-2a95a90a2dc4
Version: 1
Effective Time: 20200626
 
Premium Printing Inc.