KEEP US SAFE HAND SANITIZER- alcohol gel

KEEP US SAFE HAND SANITIZER by

Drug Labeling and Warnings

KEEP US SAFE HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Ivy Rose Inc, Guangdong Kang Rong Industrial Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Alcohol 75% v/v

Purpose

Antiseptic

Uses

• 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.

When using this product

• keep out of eyes, ears, ans 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 right away.

Do not use

• On children less than 2 months of age.
• On open skin wounds.

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

Inactive ingredients

Carbomer, glycerin, sterile distilled water, triethanolamine.

Package Labeling:50ml

Package Labeling:500ml

INGREDIENTS AND APPEARANCE

KEEP US SAFE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79247-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79247-000-00	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2020
2	NDC: 79247-000-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/15/2020

Labeler - Ivy Rose Inc (037401255)

Establishment
Name	Address	ID/FEI	Business Operations
Guangdong Kang Rong Industrial Co.,Ltd		560529816	manufacture(79247-000)