Babyo2
FDA Label NDC 72136-007

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Oxigenesis, Inc. for the product Babyo2 (NDC 72136-007). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient                                                           purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, package label - principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient                                                           Purpose

Colloidal Silver 48 mg ................................................   Skin Protectant
Colloidal Zinc   6 mg .................................................... Skin Protectant
HOCl 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 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 (Label)

Label (Label)

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