Babo Fragrance Free Diaper Cream
This is a diaper rash skin protectant cream manufactured according to the Final Monograph for Skin Protectants with 25% Zinc Oxide as the active ingredients.
Babo Fragrance Free Diaper Cream
FDA Label NDC 79265-8566
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Babo Botanicals, Inc. for the product Babo Fragrance Free Diaper Cream (NDC 79265-8566). 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 babo fragrance free diaper cream, active ingredient(s), purpose, use, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient(S)
Zinc Oxide 25%. Purpose: Skin Protectant
Purpose
Skin Protectant
Use
Helps treat and prevent diaper rash • Protects chafed skin and minor irritation associated with diaper rash • Helps seal out wetness
Warnings
For external use only.
Otc - When Using
When using this product avoid contact with eyes
Otc - Stop Use
Stop use and ask a doctor if • conditions worsens • symptoms last more than seven days • symptoms clear up and occur again within a few days
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.
Directions
Change wet and soiled diapers promptly. Cleanse the diaper area and allow to dry. Apply cream liberally and as often as necessary with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
Other Information
Protect this product from excessive heat and direct sun. You may report an adverse reaction to to the phone number or address provided below.
Inactive Ingredients
BUTYROSPERMUM PARKII (SHEA) BUTTER, CALENDULA OFFICINALIS FLOWER EXTRACT*, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*, COCOS NUCIFERA (COCONUT) OIL, EUPHORBIA CERIFERA (CANDELILLA) WAX, GLYCERIN*, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL , HYDROGENATED VEGETABLE OIL, LECITHIN, NASTURTIUM OFFICINALE (WATERCRESS) FLOWER/LEAF EXTRACT*, ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT, SPIRAEA ULMARIA (MEADOWSWEET) FLOWER EXTRACT*, THEOBROMA CACAO (COCOA) SEED BUTTER. *Certified Organic Ingredients
Package Label - Principal Display Panel
3 oz. / 85 g NDC: 79265-8566-3
* Please review the disclaimer below.
