Label: INSECT STING RELIEF PAD 01- sodium bicarbonate cloth

  • NDC Code(s): 82953-019-01
  • Packager: Cosmuses Cosmetics (Ningbo) Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 17, 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 and irritation due to

    • insect bites and stings
    • poison ivy, oak or sumac
  • Warnings

    • For external use only.

    Do not use

    • over large areas of the body
    • other than as directed

    When using this product

    • avoid contact with eyes

    Stop use and ask a doctor if

    • symptoms last for more than 7 days
    • the condiction becomes worse
    • symptoms clear up and then occur again within a few days

    Keep out of reach of children if swallowed, get medical help or contact a poison control center right away.

  • Directions

    adults and children over 2 years of age:

    • apply a small around of directly to the bite, sting or affected area and rub gently
    • re-apply as needed
    • children under 2 years of age: ask a doctor before use
  • STORAGE AND HANDLING

    other information

    store at room temperature: 59℉-86℉ (15℃-30℃)

  • Inactive Ingredients

    Aqua, Glycerin, Aloe Barbadensis Leaf Extract, Phenoxyethanol, Methylparaben.

  • PRINCIPAL DISPLAY PANEL

    82953-019

  • INGREDIENTS AND APPEARANCE
    INSECT STING RELIEF PAD  01
    sodium bicarbonate cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82953-019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE0.05 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82953-019-011 in 1 POUCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug06/14/2024
    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(82953-019)
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