CLEAN ON HAND SANITIZER- alcohol gel 
Caolion Cosmetics Co., Ltd.

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 ingredients: Alcohol 62.0% w/w

INACTIVE INGREDIENT

Inactive ingredients:

Water, Carbomer, Triethanolamine, Glycerin, Propylene Glycol, Sodium Hyaluronate, Phenoxyethanol, Panthenol, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Dipotassium Glycyrrhizate

PURPOSE

PURPOSE: SANITIZER

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 on the skin that could cause disease. Recommended for repeated use.

Directions

Directions

Take an appropriate amount on your hands and rub thoroughly to dry.
Children under 6 years of age should be supervised when using this product.

Other Information

Other Information

• Store between 15-30℃ (59-86℉)
• Avoid freezing and excessive heat above 40℃ (104℉)

PACKAGE LABEL - CLEAN ON HAND SANITIZER GEL 3mL * 10ea

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PACKAGE LABEL - CLEAN ON HAND SANITIZER GEL 30mL

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PACKAGE LABEL - CLEAN ON HAND SANITIZER GEL 300mL

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CLEAN ON HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74522-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) Alcohol62 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
Glycerin (UNII: PDC6A3C0OX)  
Propylene Glycol (UNII: 6DC9Q167V3)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Panthenol (UNII: WV9CM0O67Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74522-010-0210 in 1 CARTON04/01/2020
1NDC:74522-010-013 mL in 1 POUCH; Type 0: Not a Combination Product
2NDC:74522-010-0330 mL in 1 CONTAINER; Type 0: Not a Combination Product04/01/2020
3NDC:74522-010-04300 mL in 1 CONTAINER; 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 - Caolion Cosmetics Co., Ltd. (557792513)
Registrant - Caolion Cosmetics Co., Ltd. (557792513)
Establishment
NameAddressID/FEIBusiness Operations
KOREA COSPACK CO.,LTD.689059789manufacture(74522-010)

Revised: 4/2020
Document Id: 488a0f13-4014-4d0e-aaec-fe7e5e98619f
Set id: 8393519f-1233-4730-8e3a-19b03b018195
Version: 1
Effective Time: 20200414
 
Caolion Cosmetics Co., Ltd.