Label: BABYO2- silver, zinc liquid

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated September 17, 2020

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

View All Sections
  • Active Ingredient                                                           Purpose

    Colloidal Silver 48 mg ................................................   Skin Protectant
    Colloidal Zinc   6 mg .................................................... Skin Protectant
    HOCl 66 mg ...............................................................  Antimicrobial   

  • PURPOSE

  • Uses

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

  • Warnings

    • For external use only.
    • Do not use over puncture wounds, infections or lacerations. Avoid contact with the eyes. 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.

  • Directions

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

    Other information
    Store at 20°-25°C (68° -70° F)

  • Inactive ingredients

    Distilled water, Smectic Clay, Silicon Dioxide, HCl (buffering)

  • Package Label - Principal Display Panel

    Label

  • INGREDIENTS AND APPEARANCE
    BABYO2 
    silver, zinc liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72136-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER48 mg  in 240 mL
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC6 mg  in 240 mL
    HYPOCHLOROUS ACID (UNII: 712K4CDC10) (ZINC - UNII:J41CSQ7QDS) HYPOCHLOROUS ACID65.8 mg  in 240 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LAPONITE (UNII: D703131383)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72136-007-01240 mL in 1 TUBE; Type 0: Not a Combination Product09/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/20/2020
    Labeler - Oxigenesis, Inc. (006774725)
    Establishment
    NameAddressID/FEIBusiness Operations
    Oxigenesis, Inc.006774725manufacture(72136-007)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!