Otc - Active Ingredient
Active ingredients Purpose
Colloidal Silver 2 mg ................................................ Skin Protectant
Glycerin (Plant) 2 mg................................................ Skin Protectant
Babyo2
FDA Label NDC 72136-005
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 72136-005). 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 otc - active ingredient, otc - purpose, warnings, otc - ask doctor, otc - stop use, otc - keep out of reach of children, indications & usage, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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.
Otc - Ask Doctor
Otc - Stop Use
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.
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
* Please review the disclaimer below.
