HAND SANITIZER - ASTI- isopropyl alcohol gel 
Total Import Solutions, 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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Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

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 right away.

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 right away.

Directions

Other information

Inactive ingredients

purified water USP, Propanediol, Aloe Barbadensis Leaf Juice, Ammonium Mcryloyl Dimethyltaurate/Carboxyethyl Acrylate Crosspolymer, Tocopheryl Acetate

Package Label - Principal Display Panel

177 ml NDC: 74624-001-01 Hand Sanitizer 177 ml

473 ml NDC: 74624-001-02

Hand Sanitizer 473 ml

946 ml NDC: 74624-001-03 Hand Sanitizer 946 ml

3785 ml NDC: 74624-001-04 Hand Sanitizer 3785 ml

18927 ml NDC: 74624-001-05 - Hand Sanitizer 18927 ml

113562 ml NDC: 74624-001-06 Hand Sanitizer 113562 ml

208198 ml NDC: 74624-001-07 Hand Sanitizer 208198 ml

HAND SANITIZER - ASTI 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74624-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.04 mL  in 100 mL
PROPANEDIOL (UNII: 5965N8W85T) 2 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.1 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 21.36 mL  in 100 mL
AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI) 1.5 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74624-001-01177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/2020
2NDC:74624-001-02473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/2020
3NDC:74624-001-03946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/2020
4NDC:74624-001-043785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/2020
5NDC:74624-001-0518927 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/2020
6NDC:74624-001-06113562 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/2020
7NDC:74624-001-07208198 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/18/2020
Labeler - Total Import Solutions, Inc. (848620733)
Establishment
NameAddressID/FEIBusiness Operations
Total Import Solutions, Inc.848620733manufacture(74624-001)

Revised: 5/2020
Document Id: a62f58a7-8936-d61e-e053-2a95a90a4082
Set id: a62f3c0b-fedc-1b30-e053-2995a90a797b
Version: 4
Effective Time: 20200518
 
Total Import Solutions, Inc.