DISPOSABLE HAND SANITIZER- alcohol gel

DISPOSABLE HAND SANITIZER by

Drug Labeling and Warnings

DISPOSABLE HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by JINHUA RONGGUO TECHNOLOGY CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 75% 

Purpose

Antiseptic

Use

To decrease bacteria on the skin that could cause disease

Recommended for repeated use

Use anywhere without water

Warnings

For external use only -hands

Flammable. Keep away from heat and flame

WHEN USING

When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Avoid contact with broken skin

Do not inhale or ingest

STOP USE

Discontinue if skin becomes irritated and ask a doctor

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental ingest, seek professional assistance or contact a Poison Control Center right away.

Directions

• Wet hands thoroughly with product and rub until dry without wiping
• For children under 6, use only under adult supervision
• Not recommended for infants

Other information

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive ingredients

Water, glycerin, carbomer, aminomethyl propanol, triethanolamine, fragrance

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DISPOSABLE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78165-001
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
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CARBOMER 934 (UNII: Z135WT9208)
TROLAMINE (UNII: 9O3K93S3TK)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78165-001-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/28/2020
2	NDC: 78165-001-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/28/2020
3	NDC: 78165-001-03	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/28/2020
4	NDC: 78165-001-04	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/28/2020

Labeler - JINHUA RONGGUO TECHNOLOGY CO., LTD (554532219)

Establishment
Name	Address	ID/FEI	Business Operations
JINHUA RONGGUO TECHNOLOGY CO., LTD		554532219	manufacture(78165-001)