HAND SANITIZER- isopropyl alcohol liquid 
SMARKCHEM INDUSTRIES 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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Hand Sanitizer

Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

  1. Isopropyl Alcohol (75%, v/v)
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. water

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

Do not use

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

glycerin, hydrogen peroxide, water

Package Label - Principal Display Panel

3.785 L NDC: 75812-7500-01

3.785 L label

473 ml NDC: 75812-750-17

473 ml Label

473 ml NDC 75812-750-16

473 ml Label

946 ml NDC 75812-750-32

946 ml Label

18.927 L NDC: 75812-750-06

18.927 L Label

18.927 L NDC: 75812-750-05

18.927 L Label

HAND SANITIZER 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75812-750
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
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75812-750-013785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/15/2020
2NDC:75812-750-0618927 mL in 1 PAIL; Type 0: Not a Combination Product03/15/2020
3NDC:75812-750-32946.353 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/15/2020
4NDC:75812-750-16473.176 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/15/2020
5NDC:75812-750-0518927 mL in 1 CONTAINER; Type 0: Not a Combination Product03/15/2020
6NDC:75812-750-17473.176 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/15/2020
Labeler - SMARKCHEM INDUSTRIES INC (605375166)
Establishment
NameAddressID/FEIBusiness Operations
Smarkchem Industries INC605375166manufacture(75812-750)

Revised: 4/2020
Document Id: a3d31cfb-fae6-a735-e053-2a95a90a595b
Set id: a3d31e3b-bf5b-ae57-e053-2a95a90a86ae
Version: 2
Effective Time: 20200421
 
SMARKCHEM INDUSTRIES INC