CLEAN X PREMIUM INSTANT HAND CLEANSER- alcohol gel

Clean X Premium Instant Hand Cleanser by

Drug Labeling and Warnings

Clean X Premium Instant Hand Cleanser by is a Otc medication manufactured, distributed, or labeled by DreamDream international. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient: ALCOHOL 70% w/w

INACTIVE INGREDIENT

Inactive ingredients:

Water, Glycerin, Triethanolamine, Aloe Barbadensis Leaf Extract, Carbomer, PEG-60 Hydrogenated Castor Oil, Phenoxyethanol, Flavor, Disodium EDTA, Isopropyl Alcohol, Decyl Glucoside

PURPOSE

Purpose: ANTISEPTIC

WARNINGS

Warnings:

For external use only. Flammable. Keep away from heat or flame
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Do not use
in children less than 2 months of age
on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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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

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Uses:

Hand sanitizer to help reduce bacteria that potentially can cause disease.

Directions

Directions:

Put a small drop onto palm of your hand and massage hands together until dry.

Other information

Other information:

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLEAN X PREMIUM INSTANT HAND CLEANSER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76682-010
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
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PEG-60 Hydrogenated Castor Oil (UNII: 02NG325BQG)
Phenoxyethanol (UNII: HIE492ZZ3T)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
Isopropyl Alcohol (UNII: ND2M416302)
Decyl Glucoside (UNII: Z17H97EA6Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76682-010-01	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/01/2020

Labeler - DreamDream international (695625881)

Registrant - DreamDream international (695625881)

Establishment
Name	Address	ID/FEI	Business Operations
DreamDream international		695625881	manufacture(76682-010)