Label: ONE STOP CLEAN TO CLEAN HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77559-010-01, 77559-010-02 - Packager: LemuelBeauty 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 13, 2020
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENTS
- PURPOSE
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WARNINGS
For external use only. Flammable. Keep away from heat or flame
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When using this product ■ do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water ■ avoid contact with broken skin ■ do not inhale or ingest
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Stop use and ask a doctor if irritation or rash appears and lasts - KEEP OUT OF REACH OF CHILDREN
- Uses
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- Package Label: ONE STOP Clean to Clean Hand Sanitizer Gel 150mL
- Package Label: ONE STOP Clean to Clean Hand Sanitizer Gel 500mL
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INGREDIENTS AND APPEARANCE
ONE STOP CLEAN TO CLEAN HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77559-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) TROLAMINE (UNII: 9O3K93S3TK) Glycerin (UNII: PDC6A3C0OX) Propylene Glycol (UNII: 6DC9Q167V3) Panthenol (UNII: WV9CM0O67Z) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) ALOE VERA LEAF (UNII: ZY81Z83H0X) HYALURONATE SODIUM (UNII: YSE9PPT4TH) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77559-010-01 150 mL in 1 TUBE; Type 0: Not a Combination Product 05/01/2020 2 NDC:77559-010-02 500 mL in 1 BOTTLE, PUMP; 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 - LemuelBeauty Co.,Ltd (694520314) Registrant - LemuelBeauty Co.,Ltd (694520314) Establishment Name Address ID/FEI Business Operations KOREA COSPACK CO.,LTD. 689059789 manufacture(77559-010)