INSTANT HAND SANITIZER- alcohol liquid

Instant Hand Sanitizer by

Drug Labeling and Warnings

Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Earths Amenities, Desarrollo Tecnológico Laser, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the OTC Monograph Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use.

The hand sanitizer is manufactured using

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerin
3. Aloe Vera Extract
4. Water
5. Carbomer
6. Aminomethyl Propanol

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

To help reduce bacteria on the skin.

Warnings

For external use only. Flammable. Keep away from fire or flame

WHEN USING

Do not use on damaged or broken skin. Do not leave near fire. Wash with enough water, if it gets into eyes. Do not drink.

STOP USE

Stop use and ask a doctor if skin irritation or redness develops.

KEEP OUT OF REACH OF CHILDREN

In case of accidental ingestion, get medical help or contact a Poison Control Center right away

Directions

Apply enough gel to wet hands and rub together until dry. Use 1 to 3 times a day.

Other information

Store below 73.4F (23C)

Inactive ingredients

Water, glycerin, aloe vera extract, carbomer, aminomethyl propanol

Package Label - Principal Display Panel

60 mL NDC: 74949-001-60

250 mL NDC: 74949-001-25

495 mL NDC: 74949-001-49

1L NDC: 74949-001-01

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74949-001
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
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	1 mL  in 100 mL
ALOE VERA FLOWER (UNII: 575DY8C1ER)	1 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	27 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	1 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74949-001-60	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2020
2	NDC: 74949-001-25	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2020
3	NDC: 74949-001-49	495 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2020
4	NDC: 74949-001-01	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/13/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/13/2020

Labeler - Earths Amenities (117473288)

Establishment
Name	Address	ID/FEI	Business Operations
Earths Amenities		117473288	label(74949-001)

Establishment
Name	Address	ID/FEI	Business Operations
Desarrollo Tecnológico Laser, S.A. de C.V.		812928638	manufacture(74949-001)