SAFE ZONE- alcohol liquid

safe zone by

Drug Labeling and Warnings

safe zone by is a Otc medication manufactured, distributed, or labeled by FLORAKIN Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Alcohol

INACTIVE INGREDIENT

water, butylene glycol, clycerine, aloe barbadensis extract, glycyrrhiza uralensis (licorice) root extract, camellia sinensis leaf extract

PURPOSE

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

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.

WARNINGS

For external use only. Flammable. Keep away from heat or flame.

Do not use

• in children less than 2 months of age
• on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse 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.

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SAFE ZONE 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77502-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	210 mL  in 300 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE (UNII: V5VD430YW9)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCYRRHIZA URALENSIS ROOT (UNII: 42B5YD8F0K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77502-0001-1	300 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/04/2020

Labeler - FLORAKIN Co., Ltd. (695894484)

Registrant - FLORAKIN Co., Ltd. (695894484)

Establishment
Name	Address	ID/FEI	Business Operations
FLORAKIN Co., Ltd.		695894484	manufacture(77502-0001)