SHSNH6-4602- ethyl alcohol gel 
Shotwell Hydrogenics, 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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SHSNH6-4602 Antiseptic Topical Solution HAND SANITIZER With Vitamin E and Aloe

Drug Facts

Active ingredients(s)

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Use(s)

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

• on 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 for a doctor if irritation 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

• 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 deionized water, polyethylene glycol, AMP-acrylates vinyl isodecanoate crosspolymer, aloe barbadensis leaf juice, glycerin, fragrance, tocopheryl acetate (vitamin E acetate), FD&C Blue #1

Packaging

IMAGE

SHSNH6-4602 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73870-962
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 L  in 100 L
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73870-962-331249 L in 1 CONTAINER; Type 0: Not a Combination Product06/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/02/2020
Labeler - Shotwell Hydrogenics, LLC (108985732)
Establishment
NameAddressID/FEIBusiness Operations
Shotwell Hydrogenics, LLC108985732manufacture(73870-962)

Revised: 6/2020
Document Id: f4e5d0b0-c4f9-49dc-9251-ce994cc9a86f
Set id: ac5c1c64-d889-484e-a7cf-955a96e6e16d
Version: 1
Effective Time: 20200603
 
Shotwell Hydrogenics, LLC