ALCOHOL BASED FOAMING HAND SANITIZER- ethyl alcohol hand sanitizer liquid

Alcohol Based Foaming Hand Sanitizer by

Drug Labeling and Warnings

Alcohol Based Foaming Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by National Chemical Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

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

Alcohol Based Foaming Hand Sanitizer Approval Label

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

• 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"

WHEN USING

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

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

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

• Apply sufficient product in your palm to cover hands and rub hands together briskly until dry.
  For children under six years of age, hand sanitizer should only be used with adult supervision.

• See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

Other information

• FLAMMABLE. Keep away from fire or flame, heat, sparks and sources of static discharge.

• See "Alcohol Based Foaming Hand Sanitizer FDA Approval Label"

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"

INGREDIENTS AND APPEARANCE

ALCOHOL BASED FOAMING HAND SANITIZER 
ethyl alcohol hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71023-440
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71023-440-57	1000 mL in 1 BAG; Type 0: Not a Combination Product	02/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	02/15/2021

Labeler - National Chemical Laboratories, Inc. (002289619)

Registrant - National Chemical Laboratories, Inc. (002289619)

Establishment
Name	Address	ID/FEI	Business Operations
National Chemical Laboratories, Inc.		002289619	manufacture(71023-440)