HAND SANITIZER PREMIUM FORMULA- hand sanitizer gel

HAND SANITIZER PREMIUM FORMULA by

Drug Labeling and Warnings

HAND SANITIZER PREMIUM FORMULA by is a Otc medication manufactured, distributed, or labeled by LTP Global, ICOMAX Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use

• to decrease bacteria that potentially can cause disease
• recommended for repeated use

Warnings

For external use only : hands

Flammable. Keep away from heat or 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

Stop use and ask a doctor if

• irritation and redness develop
• condition persists for more than 72 hours

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

• wet hands thoroughly with product and allow to dry without wiping
• for children under 6, use only under adult supervision
• not recommened for infacts

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)
• Do not use on children under two months of age.

Inactive ingredients

Water, Glycerin, Carbomer, Trolamine, L-Menthol, Green Tea Leaf, Aloe Vera Leaf

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER PREMIUM FORMULA 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73812-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.001 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.25 mL  in 100 mL
LEVOMENTHOL (UNII: BZ1R15MTK7)	0.02 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)	0.68 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	28.048 mL  in 100 mL
GREEN TEA LEAF (UNII: W2ZU1RY8B0)	0.001 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73812-002-50	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/20/2020

Labeler - LTP Global (694215916)

Establishment
Name	Address	ID/FEI	Business Operations
ICOMAX Co., Ltd.		694834031	manufacture(73812-002)