Drug labels

Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash

ZINC OXIDE · Babo Botanicals, Inc. · TOPICAL

HUMAN OTC DRUG
Open FDA's page for this record
Set ID
186a9642-cd73-adfb-e063-6394a90a75c7
ID
186a9642-cd74-adfb-e063-6394a90a75c7
Effective time
20240514
Version
1
SPL product data elements

Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash Zinc Oxide FILIPENDULA ULMARIA FLOWER SHEA BUTTER CHAMOMILE ZINC OXIDE ZINC OXIDE NASTURTIUM OFFICINALE FLOWERING TOP COCOA BUTTER CALENDULA OFFICINALIS FLOWER LECITHIN, SUNFLOWER ROSEMARY COCONUT OIL SUNFLOWER OIL CANDELILLA WAX

SPL unclassified section
Drug Facts
Active ingredient
Active ingredient Zinc Oxide 25%
Purpose
Purpose Skin Protectant
Indications and usage
Uses Helps treat and prevent diaper rash Protects minor skin irritation associated with diaper rash Helps seal out wetness
Warnings

Warnings For external use only When using this product do not get into eyes Stop use and ask doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

When using
When using this product do not get into eyes
Stop use
Stop use and ask doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days
Keep out of reach of children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Dosage and administration

Directions Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Other safety information
Other information Protect this product from excessive heat and direct sun May stain some fabrics and surfaces
Inactive ingredient

Inactive ingredients Butyrospermum Parkii (Shea) Butter*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Cocos Nucifera (Coconut) Oil*, Euphorbia Cerifera (Candelilla) Wax, 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

Questions
Questions or comments? Call 1-800-422-2987 M-F 9:00AM-5:00PM EST
Package label principal display panel
Product Packaging 1
Harmonized identifiers (openFDA)
Application number
M016
Brand name
Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash
Generic name
ZINC OXIDE
Manufacturer name
Babo Botanicals, Inc.
Product NDC
79265-8580
Product type
HUMAN OTC DRUG
Route
TOPICAL
Substance name
ZINC OXIDE
RxCUI
1125471
SPL ID
186a9642-cd74-adfb-e063-6394a90a75c7
SPL set ID
186a9642-cd73-adfb-e063-6394a90a75c7
Package NDC
79265-8580-1
Is original packager
true
UNII
SOI2LOH54Z
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.