Otc - Active Ingredient
Active Ingredient
Zinc Oxide 10%
Baby Mantra Diaper Cream Ointment
FDA Label NDC 76348-825
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Renu Laboratories, Llc for the product Baby Mantra Diaper Cream (NDC 76348-825). 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, indications & usage, warnings, otc - stop use, otc - do not use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Skin Protectant
Indications & Usage
Uses:
- Helps treat and prevent diaper rash.
- Protects chafed skin due to diaper rash and helps protect skin from wetness.
- Helps prevent and temporarily protects chafed, chapped, cracked or wind-burned skin and lips.
Warnings
Warnings: For external use only.
When using this product, do not get into eyes.
Stop use and ask a doctor if
- condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days
- deep or puncture wounds
- animal bites
- serious burns
Do not use on:
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Stop Use
Stop use and ask a doctor if
- condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days
Otc - Do Not Use
Do not use on:
- deep or puncture wounds
- animal bites
- serious burns
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions:
- Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.
- Apply ointment liberally, as often as necessary, with each diaper change, especially at bedtime or anytime exposure to wet diaper
Inactive Ingredient
Inactive Ingredients:
Helianthus Annuus (Sunflower) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Beeswax (White), Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol (D-alpha), Aqua (Water), Glycerin
Other Safety Information
Store at room temperature
Recent Major Changes
For Indications and Usage section : Not a major change - We have only updated our Effective Date.
For Dosage and Administration section: Not a major change - we have only updated our Effective Date.
Package Label.Principal Display Panel
TUBE ARTWORK
* Please review the disclaimer below.
