INSTANT HAND ANTISEPTIC- alcohol gel 
ASP Global, LLc

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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Instant Hand Antiseptic

Drug Facts

Active Ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

For hand washing to decrease bacteria on the skin.

Recommended for repeated use.

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Avoid contact with broken skin.

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 appears and lasts.

Keep out of reach of children. If swallowed, get medical help.

Directions

Not recommended for infants.

Wet hands thoroughly with product and allow to dry without wiping.

Children under 6 years of age should be supervised when using this product.

Other Information

Do not store above 110°F. May discolor some fabrics.

Inactive Ingredients

Water, Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Fragrance.

Distributed by:
ASP Global, LLC
7800 Third Flag Parkway,
Austell, GA 30168, USA

PRINCIPAL DISPLAY PANEL - 53 mL Bottle Label

Wellstar

Instant Hand Antiseptic

62% w/w Ethyl Alcohol

1.9 FL OZ / 53 mL

Distributed by:
ASP Global, LLC
7800 Third Flag Parkway,
Austell, GA 30168, USA

Rev 00

PRINCIPAL DISPLAY PANEL - 53 mL Bottle Label
INSTANT HAND ANTISEPTIC 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59448-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Glycerin (UNII: PDC6A3C0OX)  
Propylene Glycol (UNII: 6DC9Q167V3)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
Trolamine (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59448-008-0153 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E10/01/2021
Labeler - ASP Global, LLc (080361159)

Revised: 10/2021
Document Id: a8794ec0-cedb-43b3-8de0-65fd68f33ee3
Set id: 9aca3f89-cdde-430c-8eb6-43a3ac3fc0df
Version: 1
Effective Time: 20211005
 
ASP Global, LLc