HYDRI-SAN 3C HAND SANITIZER- alcohol solution

Hydri-San 3C Hand Sanitizer by

Drug Labeling and Warnings

Hydri-San 3C Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Hydrite Chemical Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Hydrite Chemical Co. will manufacture a hand sanitizer per FDA’s TEMPORARY POLICY FOR PREPARATION OF CERTAIN ALCOHOL-BASED HAND SANITIZER PRODUCTS DURING THE PUBLICH HEALTH EMERGENCY (COVID-19) GUIDANCE FOR INDUSTRIES which will be sold in drums.

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:
a. 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; or Isopropyl Alcohol (75%, v/v) in an aqueous solution.
b. Glycerol (1.45% v/v).
c. Hydrogen peroxide (0.125% v/v).
d. 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 80% v/v. Purpose: Antiseptic

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

Do not use
in children less than 2 months of age
on open skin wounds

WHEN USING

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

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

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

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

Drum of 207 L (207,000 mL)

Drum of 18.9 L (18,900 mL)

INGREDIENTS AND APPEARANCE

HYDRI-SAN 3C HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64487-2206
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 L  in 100 L

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1.45 L  in 100 L
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 L  in 100 L
WATER (UNII: 059QF0KO0R)	18.425 L  in 100 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64487-2206-1	207 L in 1 DRUM; Type 0: Not a Combination Product	03/26/2020
2	NDC: 64487-2206-4	18.9 L in 1 PAIL; Type 0: Not a Combination Product	04/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/26/2020

Labeler - Hydrite Chemical Co. (006435887)

Establishment
Name	Address	ID/FEI	Business Operations
Hydrite Chemical Co.		094362464	manufacture(64487-2206)