Label: INSECT STING RELIEF LATEX 01- sodium bicarbonate lotion

  • NDC Code(s): 82953-020-01
  • Packager: Cosmuses Cosmetics (Ningbo) Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 24, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Fact

  • Active Ingredient

    Sodium bicarbonate (Baking Soda) 5%

  • Purpose

    Skin Protectant

  • Uses

    temporary relief of itching, assicuated with minor skin irritations, inflammation and rashes due to:

    eczema, insect bites, poison ivy, oak or sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and more

  • Warnings

    • For external use only.

    Do not use

    • in or near the eyes
    • for diaper rash; ask a doctor

    Ask a doctor before use if you are

    using any other hydrocortisone product

    Stop use and ask a doctor if

    • condition worsens or if symptoms persist for more than 7 days
    • symptoms last more than 7 days or clear up and occur again within a few days

    Keep out of reach of children if ingested, contact a poison control center right away.

  • Directions

    • apply to affected area not more than 3 to 4 times daily
    • children under 2 years, do not use; ask a doctor
  • STORAGE AND HANDLING

    Other information

    protect from Excessive Heat: (40℃/104℉)

  • Inactive Ingredients

    Aqua, Paraffinum Liquidum, Glyceryl Stearate, Cetearyl Alcohol, Ceteth-25, Beeswax, Glycerin, Aloe Barbadensis Leaf Extract, Phenoxyethanol, Methylparaben, Propylparaben, Disodium EDTA, BHT.

  • PRINCIPAL DISPLAY PANEL

    82953-020

  • INGREDIENTS AND APPEARANCE
    INSECT STING RELIEF LATEX  01
    sodium bicarbonate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82953-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CETETH-25 (UNII: 5KLY4IOG20)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82953-020-010.9 g in 1 POUCH; Type 1: Convenience Kit of Co-Package06/14/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01606/14/2024
    Labeler - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)
    Registrant - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmuses Cosmetics (Ningbo) Co., Ltd.725290934manufacture(82953-020)
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