MISSHA OH MY CLEAN THE PURE SANITIZER- alcohol gel 
Able C&C 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

Alcohol 62% v/v

INACTIVE INGREDIENT

Water, Carbomer, Triethanolamine, Glycerin, Tocopheryl Acetate, Salvia Officinalis (Sage) Extract, Hedera Helix (Ivy) Extract

PURPOSE

Antiseptic

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.

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease.
For use when soap and water are not available.

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.
■ Avoid direct inhalation of vapors during application. (Headaches and irritation to mucous membranes may occur when directly inhaled.)
■ This product is intended only for hand sanitizing.
■ To prevent contents from drying out and contaminants from entering, close lid completely after use.
■ Keep product in its original container as storing the product in anything other than the original container may result in accidents or cause the integrity of the product to diminish.
■ Do not use over bandages, castings, etc. as irritation may occur.

Other information

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottle

MISSHA OH MY CLEAN THE PURE SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13733-450
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL310 mL  in 500 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
Glycerin (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SALVIA OFFICINALIS ROOT (UNII: 236QY0A1BL)  
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13733-450-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/01/2020
Labeler - Able C&C Co., Ltd. (689540284)
Registrant - Able C&C Co., Ltd. (689540284)
Establishment
NameAddressID/FEIBusiness Operations
SISKINKOREA CO.,LTD.695625974manufacture(13733-450)

Revised: 5/2020
Document Id: 04c40213-9f1f-4776-b7dc-2277adf6e4fe
Set id: 051d096f-ae69-4493-a4f5-c36695f885d7
Version: 1
Effective Time: 20200513
 
Able C&C Co., Ltd.