CLEAN AND HAND- alcohol gel 
Enprani 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% w/w

INACTIVE INGREDIENT

Inactive ingredients:
Water, Butylene Glycol, Carbomer

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:

• 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

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

PACKAGE LABEL - CLEAN & HAND GEL 55mL

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PACKAGE LABEL - CLEAN & HAND GEL 250mL

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PACKAGE LABEL - CLEAN & HAND GEL 500mL

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CLEAN AND HAND 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69551-051
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)  
Butylene Glycol (UNII: 3XUS85K0RA)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69551-051-0155 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
2NDC:69551-051-02250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2020
3NDC:69551-051-03500 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 - Enprani Co., Ltd. (631100112)
Registrant - Enprani Co., Ltd. (631100112)
Establishment
NameAddressID/FEIBusiness Operations
Opseve KOREA Co.,Ltd.690048629manufacture(69551-051)

Revised: 4/2020
Document Id: 6cc8335e-a192-4c2d-862f-bad790d23577
Set id: 3144d658-1498-4f0f-ab5f-aa9a16f37f0b
Version: 1
Effective Time: 20200422
 
Enprani Co., Ltd.