Label: BABYO2- colloidal silver and glycerin solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated February 26, 2019

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  • ACTIVE INGREDIENT

    Active ingredients                                                          Purpose

    Colloidal Silver 2 mg ................................................   Skin Protectant

    Glycerin (Plant) 2 mg................................................   Skin Protectant

  • PURPOSE

    Uses

    Relieves and prevents the discomfort and symptoms from: diaper rash, chaffed skin, minor burns and abrasions.

  • WARNINGS

    Warnings

    For external use only.

    Do not use over puncture wounds, infections or lacerations.

    Avoid contact with the eyes.

  • ASK DOCTOR

  • WHEN USING

  • STOP USE

    Stop use and ask a doctor if condition worsens or does not improve in 7 days.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    Directions

    Change wet and solid diapers promptly. Cleanse diaper area and dry. Apply ointment liberally as often necessary with every diaper change, especially at bedtime.

  • STORAGE AND HANDLING

    Other information

    Sstore at 20°-25°C (68° -70° F)

  • INACTIVE INGREDIENT

    Inactive ingredients

    Distilled water, Sodium Chloride, Hydroxypropyl Starch Phosphate.

  • DOSAGE & ADMINISTRATION

    Marketed & Distributed by:

    Oxigenesis, Inc.
    2917 Union Road, Suite B
    Paso Robles, CA 93446 USA
    805-549-0275

  • PRINCIPAL DISPLAY PANEL

    BabyO2

  • INGREDIENTS AND APPEARANCE
    BABYO2 
    colloidal silver and glycerin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72136-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER2 mg  in 240 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2 mg  in 240 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE NA-22 (UNII: VMP9781061)  
    HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) (UNII: 9M44R3409A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72136-005-01240 mL in 1 TUBE; Type 0: Not a Combination Product02/26/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/26/2019
    Labeler - Oxigenesis, Inc. (006774725)
    Registrant - Oxigenesis, Inc. (006774725)
    Establishment
    NameAddressID/FEIBusiness Operations
    Oxigenesis, Inc.006774725manufacture(72136-005)
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