NDC 72136-007 Babyo2

Silver, Zinc

NDC Product Information

Babyo2 with NDC 72136-007 is a a human over the counter drug product labeled by Oxigenesis, Inc.. The generic name of Babyo2 is silver, zinc. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Oxigenesis, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Babyo2 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SILVER 48 mg/240mL
  • ZINC 6 mg/240mL
  • HYPOCHLOROUS ACID 65.8 mg/240mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • LAPONITE (UNII: D703131383)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Oxigenesis, Inc.
Labeler Code: 72136
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 09-20-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Babyo2 Product Label Images

Babyo2 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient                                                           Purpose

Colloidal Silver 48 mg ................................................   Skin ProtectantColloidal Zinc   6 mg .................................................... Skin ProtectantHOCl 66 mg ...............................................................  Antimicrobial

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.

Otc - 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 informationStore at 20°-25°C (68° -70° F)

Inactive Ingredients

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

* Please review the disclaimer below.