Label: MISSHA OH MY CLEAN THE PURE SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 13733-451-01 - Packager: Able C&C Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated May 25, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
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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 woundsWhen 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
- Uses
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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
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MISSHA OH MY CLEAN THE PURE SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13733-451 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 86.8 mL in 140 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13733-451-01 140 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/01/2020 Labeler - Able C&C Co., Ltd. (689540284) Registrant - Able C&C Co., Ltd. (689540284) Establishment Name Address ID/FEI Business Operations SISKINKOREA CO.,LTD. 695625974 manufacture(13733-451)