HAND SANITIZER- isopropyl alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Round Bridge Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 75% 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. Keep away from heat or flame

Do not use

• in children less than 2 months of age

WHEN USING

When using this product keep out of eyes, ears, and mouth.

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.
• Children under 6 years of age should be supervised when using this product.

Other information

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

Inactive ingredients

Aqua, Glycerin, Carbomer, Triethanolamine

Package Label - Principal Display Panel

59 ml NDC: 34839-002-01

118 ml NDC: 34839-002-02

236 ml NDC: 34839-002-03

500 ml NDC: 34839-002-04

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34839-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)	0.25 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.25 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34839-002-02	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2020
2	NDC: 34839-002-03	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2020
3	NDC: 34839-002-04	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2020
4	NDC: 34839-002-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2020

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

Labeler - Round Bridge Inc (103309063)

Registrant - Round Bridge Inc (103309063)

Establishment
Name	Address	ID/FEI	Business Operations
Round Bridge Inc		103309063	manufacture(34839-002) , label(34839-002) , pack(34839-002)