Label: SMD COSMETICS CLEAN AND PURE HAND SANITIZER- alcohol solution

  • 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 8, 2020

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredient(s)

    Ethanol 61%

  • Purpose

    Antiseptic

  • Use(s)

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

  • 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 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 Poison Control Center right away.

  • 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

    • Store between 15-30C (59-86F)

    • Avoid freezing and excessive heat above 40C (104F)

  • INACTIVE INGREDIENT

    Inactive ingredients Water, Camellia Sinensis Leaf Extract, Morus Alba Root Extract, Aloe Barbadensis Leaf Powder, Sodium Hyaluronate, Carbomer, Triethanolamine, Fragrance

  • SPL UNCLASSIFIED SECTION

    PURIFY       •       CLEANSE       •        HYDRATE

    100% PLANT BASED

    ALOE • GREEN TEA • WHITE MULBERRY

    ELIMINATES GERMS WITH 61% ALCOHOL ANTISEPTIC

    NON-STERILE SOLUTION

    PARABEN-FREE • CRUELTY-FREE • CLEAN • NATURAL • SAFE-FRAGRANCE

    SMD Cosmetics’ plant based hand sanitizer eliminates germs while keeping hands clean and hydrated.

    Distributed by SMD Cosmetics, Intl., Calabasas, CA 91302

    Manufactured by Saimdang

    143, Yangcheongsongdae-gil, Ochang-eup, Cheongwon-gu, Cheongju-si,

    Chungcheongbuk-do, KOREA

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    SMD COSMETICS CLEAN AND PURE HAND SANITIZER 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75775-061
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL61 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MORUS ALBA ROOT (UNII: CST1G9BZGD)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75775-061-50500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/23/2020
    Labeler - Smd Cosmetics, Inc. (111920148)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAIMDANG Cosmetics CO.,LTD.689191286manufacture(75775-061)