HAND SANITIZER- ethyl alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Zhejiang RIFESHOW Cosmetics Co., Ltd., DERMARITE INDUSTRIES, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 75%

Purpose

Antiseptic

Use

• For cleansing/sanitizing of the hands when soap and water are not available.
• Recommended for repeated use.

Warnings

• For external use only.
• Flammable. Keep away from heat or flame.
• Avoid contact with eyes. In case of contact, flush thoroughly with water.

STOP USE

Stop use and seek medical attention if skin irritation develops.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away.

Directions

• Apply generously, work into hands and allow to dry without wiping.
• Children under six should be supervised while using this product.

Other information

• Do not store above 110℉.
• May discolor some fabrics or surfaces.
• Report adverse events to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047.

Inactive ingredients

Deionized Water, Glycerol, Carbomer, Triethanolamine.

QUESTIONS

Call 1-800-337-6296

Mon-Fri 9AM- 5PM EST.

Package Label - Principal Display Panel

236 mL NDC: 56084-028-01

500 mL NDC: 56084-028-02

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56084-028
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER 934 (UNII: Z135WT9208)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56084-028-01	236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	11/13/2020
2	NDC: 56084-028-02	500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	11/13/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/13/2020

Labeler - Zhejiang RIFESHOW Cosmetics Co., Ltd. (560843477)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang RIFESHOW Cosmetics Co., Ltd.		560843477	manufacture(56084-028)

Establishment
Name	Address	ID/FEI	Business Operations
DERMARITE INDUSTRIES, LLC		883925562	label(56084-028)