ALCOHOL BASED FOAMING HAND SANITIZER- ethyl alcohol hand sanitizer liquid 
National Chemical Laboratories, 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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Alcohol Based Foaming Hand Sanitizer

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic, Antimicrobial

Alcohol Based Foaming Hand Sanitizer Approval Label Labeling Information

Purpose

Antiseptic, Hand Sanitizer, Antimicrobial

See Image "Alcohol Based Foaming Hand Sanitizer Approval Label"

Use

• Hand sanitizing to help reduce microorganisms on the skin • Recommended for repeated use
• Use this product when soap and water are not available • Do not use when hands are visibly soiled

See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

Warnings

For external use only.
FLAMMABLE. Keep away from fire or flame, heat, sparks and sources of static discharge.

See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

Do Not Use

When using this product avoid contact with eyes. In case of eye contact, rinse eyes thoroughly with water.

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

See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

Stop use if irritation or redness develops, if condition persist for more than 72 hours consult a physician.

See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

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

See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

Directions

Other information

Inactive ingredients

Cocamidopropyl PG-Dimonium Chloride Phosphate, Denatonium benzoate, Dimethicone PEG-7 Phosphate, PEG-8 Dimethicone, PEG-10 Dimethicone, tert-Butyl alcohol, Water

See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

Package Label - Principal Display Panel

1000 ml NDC: 71023-440-57

See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

Principal Package Label

ALCOHOL BASED FOAMING HAND SANITIZER 
ethyl alcohol hand sanitizer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71023-440
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
PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
DIMETHICONE PEG-7 PHOSPHATE (UNII: WTP86Y84TV)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71023-440-571000 mL in 1 BAG; Type 0: Not a Combination Product02/15/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E02/15/2021
Labeler - National Chemical Laboratories, Inc. (002289619)
Registrant - National Chemical Laboratories, Inc. (002289619)
Establishment
NameAddressID/FEIBusiness Operations
National Chemical Laboratories, Inc.002289619manufacture(71023-440)

Revised: 10/2022
Document Id: ec1ce929-2135-9a66-e053-2995a90a3664
Set id: bb623d85-4fc0-068d-e053-2995a90a7958
Version: 3
Effective Time: 20221028
 
National Chemical Laboratories, Inc.