PURE HONEST HAND SANITIZER GEL- alcohol gel

PURE HONEST HAND SANITIZER Gel by

Drug Labeling and Warnings

PURE HONEST HAND SANITIZER Gel by is a Otc medication manufactured, distributed, or labeled by Primoris International Co., Ltd., MEGACOS MANUFACTURING Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Alcohol 70% w/w

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.

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.

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.
■ Avoid direct inhalation of vapors during application. (Headaches and
irritation to mucous membranes may occur when directly inhaled.)
■ This product is intended only for hand sanitizing.
■ To prevent contents from drying out and contaminants from entering, close
lid completely after use.
■ Keep product in its original container as storing the product in anything
other than the original container may result in accidents or cause the integrity
of the product to diminish.
■ Do not use over bandages, castings, etc. as irritation may occur.

OTHER INFORMATION

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

INACTIVE INGREDIENTS

Water, Glycerin, Carbomer, Fragrance, Aminomethyl Propanol, Aloe Vera Gel, Allantoin, Panthenol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PURE HONEST HAND SANITIZER GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79925-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	350 mL  in 500 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PANTHENOL (UNII: WV9CM0O67Z)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ALLANTOIN (UNII: 344S277G0Z)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79925-500-01	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/03/2020

Labeler - Primoris International Co., Ltd. (694921686)

Establishment
Name	Address	ID/FEI	Business Operations
MEGACOS MANUFACTURING Co., Ltd		694745986	manufacture(79925-500)