AISLINN HAND SANITIZER GEL- alcohol gel 
Alcaraz Silva, Hector Alberto Tonathiú

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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Aislinn Hand Sanitizer Gel - 70% Alcohol

Ethyl alcohol 70% v/v

Antiseptic

Hand Sanitizer to help reduce bacteria that potentially can cause disease
Recommended for repeated use

For external use only.

Flammable. Keep away from fire or flame.

When using this product keep out of eyes.

In case of contact with eyes, flush thoroughly with water

Avoid contact on broken skin. Do not inhale or ingest.

Stop use and ask a doctor if irritation or rash occurs.

Condition persists for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hand thoroughly with product and rub into skin until dry.

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

Store between 15-30ºC (59-89ºF)

Avoid freezing and excessive heating 40ºC (104ºF)

Carbomer 940, Glycerin, Triethanolamine and Water

NDC 79664-100-01 500mL

Hand Sanitizer 500mL

NDC 79664-100-02 1000mL

Hand Sanitizer 1000mL

NDC 79664-100-03 4000mL

Hand Sanitizer 4000mL

NDC 79664-100-04 20000mL

Hand Sanitizer 20000mL

NDC 79664-100-05 200000mL

Hand Sanitizer 200000mL

AISLINN HAND SANITIZER GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79664-100
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)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79664-100-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/28/2020
2NDC:79664-100-021000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/28/2020
3NDC:79664-100-034000 mL in 1 JUG; Type 0: Not a Combination Product07/28/2020
4NDC:79664-100-0420000 mL in 1 CANISTER; Type 0: Not a Combination Product07/28/2020
5NDC:79664-100-05200000 mL in 1 CYLINDER; Type 0: Not a Combination Product07/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/28/2020
Labeler - Alcaraz Silva, Hector Alberto Tonathiú (951580213)

Revised: 7/2020
Document Id: ab88474b-7fd6-8eae-e053-2a95a90ab99d
Set id: ab88474b-7fd5-8eae-e053-2a95a90ab99d
Version: 1
Effective Time: 20200728
 
Alcaraz Silva, Hector Alberto Tonathiú