Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash Spray
FDA Label NDC 79265-8576

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 Botanicals Sensitive Baby Fragrance Free Diaper Rash (NDC 79265-8576). 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, when using this product, stop use and ask a doctor, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ When Using This Product

→ Stop Use And Ask A Doctor

→ Keep Out Of Reach Of Children.

→ Directions

→ Inactive Ingredients

→ Company Information

→ Product Packaging

Active Ingredient

Zinc Oxide 14.9%

Purpose

Skin Protectant

Uses

Helps treat and prevent diaper rash
Protects minor skin irritation associated with diaper rash
Helps seal out wetness

Warnings

For external use only

When Using This Product

avoid contact with eyes

Stop Use And Ask A Doctor

if symptoms last more than 7 days or clears up and occurs again within a few days.

Keep Out Of Reach Of Children.

If swallowed get medical help or contact a Poison Control Center right away.

Directions

Shake well before use
Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry
Spray 4-6 inches away from skin.
Spray product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
No need to rub in.

Inactive Ingredients

Water (Aqua), Olea Europaea (Olive) Fruit Oil, Propanediol, Ricinus Communis (Castor) Seed Oil, Bentonite, Glyceryl Rosinate, Cetearyl Alcohol, Butyrospermum Parkii (Shea) Butter*, Aloe Barbadensis (Aloe Vera) Leaf Juice*, Helianthus Annuus (Sunflower) Seed Oil*, Chamomilla Recutita (Matricaria) Flower Extract*, Calendula Officinalis Flower Extract*, Nasturtium Officinale (Watercress) Flower/Leaf Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Olea Europaea (Olive) Oil Unsaponifiables, Caprylyl Glycol, Microcrystalline Cellulose, Coco-Glucoside, Glycerin, Caprylhydroxamic Acid, Cellulose Gum, Glyceryl Oleate.

*Certified Organic Ingredients