Label: HAND SANITIZER - ASTI- isopropyl alcohol gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 74624-001-01, 74624-001-02, 74624-001-03, 74624-001-04, view more74624-001-05, 74624-001-06, 74624-001-07 - Packager: Total Import Solutions, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated May 18, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
-
WHEN USING
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
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
-
INGREDIENTS AND APPEARANCE
HAND SANITIZER - ASTI
isopropyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74624-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:74624-001-01 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/18/2020 2 NDC:74624-001-02 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/18/2020 3 NDC:74624-001-03 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/18/2020 4 NDC:74624-001-04 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/18/2020 5 NDC:74624-001-05 18927 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/18/2020 6 NDC:74624-001-06 113562 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/18/2020 7 NDC:74624-001-07 208198 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/18/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/18/2020 Labeler - Total Import Solutions, Inc. (848620733) Establishment Name Address ID/FEI Business Operations Total Import Solutions, Inc. 848620733 manufacture(74624-001)