INSTANT HAND SANITIZER 70% ALCOHOL- alcohol liquid

Instant Hand Sanitizer by

Drug Labeling and Warnings

Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Davemed Healthcare Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, 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. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin. Recommended for repeated use

Warnings

Flammable.

Keep away from fire or flame

For external use only

When using this product

• avoid contact with eyes
• in case of eye contact, immediately flush eyes with water, call a doctor
• avoid contact with broken skin

Discontinue use if irrittion or redness develops. If condition persists for more than 72 hours, consult a doctor.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. Children should only use this product under adult supervision

Do not drink. Not edible. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

• Place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry. Recommended for repeated use

Other information

• Do not store above 105F
• May discolor some fabrics.
• Harmful to wood finishes and plastics

Inactive ingredients

aloe bardensis leaf extract, caprylyl glycol carbomer, glycerin, isopropyl alcohol, isopropyl myristate, hydrochloric acid, sodium chloride

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER  70% ALCOHOL
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70897-009
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
HYDROCHLORIC ACID (UNII: QTT17582CB)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70897-009-01	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - Davemed Healthcare Co., Ltd (529128716)

Establishment
Name	Address	ID/FEI	Business Operations
Davemed Healthcare Co., Ltd		529128716	manufacture(70897-009)