CLEAN X PREMIUM INSTANT HAND CLEANSER- alcohol gel 
DreamDream international

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

Image of bottle

CLEAN X PREMIUM INSTANT HAND CLEANSER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76682-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL350 mL  in 500 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76682-010-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/01/2020
Labeler - DreamDream international (695625881)
Registrant - DreamDream international (695625881)
Establishment
NameAddressID/FEIBusiness Operations
DreamDream international695625881manufacture(76682-010)

Revised: 5/2020
Document Id: 57eb4a61-fcd1-4b27-bd38-2e6cef34c938
Set id: c56116db-a924-45ea-8470-179813b3bf8b
Version: 1
Effective Time: 20200501
 
DreamDream international