Label: THE ITCH ERASER SENSITIVE- sodium bicarbonate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 September 1, 2020

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  • Drug Facts

  • Active Ingredient

    Sodium Bicarbonate (BakingSoda) 5%

  • Purpose

    Skin Protectant

  • ​Uses

    ​Temporarily protects and helps relieve minor skin irritation and itching due to:

    • ​insect bites
    • poison: ivy, oak, and sumac

  • ​Warnings

    ​For external use only

  • When using this product

    • do not get into eyes
  • Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and 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.

  • SPL UNCLASSIFIED SECTION

    ​If in eyes ​flush with water for 15 minutes and call a doctor

  • ​Directions

    • ​Adults and children 2 years and older​ dab directly on bite or sting, rub gently and re-apply as needed
    • ​children under 2 years of age:​ ask a doctor.
  • ​Inactive Ingredients

    Aloe Vera, Dimethicone, Emulsifying Wax, Eucalyptus Oil, Oleth-3 Phosphate, Oleth-10, Phosphate, Purified Water, Sodium Hydroxide, Vitamin E Acetate, and Tea Tree Oil

  • Package Labeling:

    Box

  • INGREDIENTS AND APPEARANCE
    THE ITCH ERASER SENSITIVE 
    sodium bicarbonate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90107-2420
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    OLETH-10 (UNII: JD797EF70J)  
    PHOSPHATE ION (UNII: NK08V8K8HR)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:90107-2420-14 in 1 BOX09/01/2020
    120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/01/2020
    Labeler - Adventure Ready Brands (064437304)
    Registrant - Adventure Ready Brands (064437304)
    Establishment
    NameAddressID/FEIBusiness Operations
    Adventure Ready Brands064437304manufacture(90107-2420)
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