PREVENTMD EXTRACLEAN HYDRATING HAND SANITIZER- alcohol gel

PREVENTMD EXTRACLEAN HYDRATING HAND SANITIZER by

Drug Labeling and Warnings

PREVENTMD EXTRACLEAN HYDRATING HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Iontera, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Alcohol 63% 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.

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.

Other information

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

Inactive ingredients

Water, Butylene Glycol, Glycerin, Sodium Hyaluronate, Aloe Barbadensis Leaf Juice, Hydrolyzed Collagen, Carbomer, 1,2-Hexanediol, Ethylhexylglycerin, Triethanolamine, Phenoxyethanol, Fragrance

Company Information

DIST. BY/PAR RARE BEAUTY BRANDS, INC. 83 MORSE ST. NORWOOD MA, 02062

ALL RIGHTS RESERVED. DESIGNED IN THE USA. MADE IN KOREA.

Product Packaging - 50 mL

preventMD

EXTRACLEAN

hydrating

hand sanitizer

contains 63% alcohol

50 mL 1.7 Fl. Oz.

INGREDIENTS AND APPEARANCE

PREVENTMD EXTRACLEAN HYDRATING HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72204-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	63 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72204-003-01	50 mL in 1 POUCH; Type 0: Not a Combination Product	04/22/2020
2	NDC: 72204-003-02	23 mL in 1 POUCH; Type 0: Not a Combination Product	04/22/2020
3	NDC: 72204-003-03	50 in 1 BOX	04/22/2020
3		3.5 mL in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 72204-003-04	30 in 1 BOX	04/22/2020
4		3 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/22/2020

Labeler - Iontera, Inc (004818058)