FORMALBEE DAILY INSTANT HAND SANITIZER- alcohol gel

FORMALBEE Daily Instant Hand Sanitizer by

Drug Labeling and Warnings

FORMALBEE Daily Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Natuzen Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Ethyl alcohol 70% v/v

INACTIVE INGREDIENT

Inactive ingredients:

Water, Butylene Glycol, Carbomer, Triethanolamine, PEG-60 Hydrogenated Castor Oil, Limonene, Fragrance, Aloe Barbadensis Leaf Extract, Citrus Limon (Lemon) Fruit Extract, Citral

PURPOSE

Purpose: Hand Sanitizer

WARNINGS

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 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 or contact a Poison Control Center right away.
Do not eat.

Uses

Uses:

Hand sanitizer to help reduce bacteria on the skin

Directions

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FORMALBEE DAILY INSTANT HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70930-140
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)
Butylene Glycol (UNII: 3XUS85K0RA)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
PEG-60 Hydrogenated Castor Oil (UNII: 02NG325BQG)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LEMON (UNII: 24RS0A988O)
CITRAL (UNII: T7EU0O9VPP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70930-140-01	300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/01/2020

Labeler - Natuzen Co.,Ltd. (688201272)

Registrant - Natuzen Co.,Ltd. (688201272)

Establishment
Name	Address	ID/FEI	Business Operations
Natuzen Co.,Ltd.		688201272	manufacture(70930-140)