Label: YIXIN SUNLIN INSTANT HAND SANITIZER- alcohol gel

  • 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 October 10, 2020

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

  • SPL UNCLASSIFIED SECTION

    NA

  • Active Ingredient(s)

    Alcohol 75% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic

  • Use

    For hand washing to decrease bacterial on the skin, only when water is not available

  • Warnings

    Flammable. Keep away from fire and flame. For external use only.

  • WHEN USING

    When using this product, do not get into eyes. If contact occurs, rinse thoroughly with water. May discolor some fabrics

  • STOP USE

    Stop use and ask a doctor if irritation and redness develops

  • 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.

  • Directions

    Wet hands thoroughly with product and allow to dry without wiping

  • Other information

    Store below 105F

  • Inactive ingredients

    Water, carbomer, triethanolamine, glycerol

  • Package Label - Principal Display Panel

    image description

  • INGREDIENTS AND APPEARANCE
    YIXIN SUNLIN INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75112-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCEROL FORMAL (UNII: 3L7GR2604E)  
    CARBOMER 934 (UNII: Z135WT9208)  
    TRIETHANOLAMINE SULFATE (UNII: MV1V89M17O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75112-001-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/14/2020
    2NDC:75112-001-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/14/2020
    3NDC:75112-001-0360 mL in 1 BOTTLE; Type 0: Not a Combination Product04/14/2020
    4NDC:75112-001-04237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/14/2020
    5NDC:75112-001-05300 mL in 1 BOTTLE; Type 0: Not a Combination Product04/14/2020
    6NDC:75112-001-061000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/14/2020
    7NDC:75112-001-073780 mL in 1 BOTTLE; Type 0: Not a Combination Product04/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/14/2020
    Labeler - Zhejiang Shenying Technology Co., Ltd. Jiaojiang Branch (414137820)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Shenying Technology Co., Ltd. Jiaojiang Branch414137820manufacture(75112-001)