babo botanicals sensitive baby fragrance free diaper rash cream

babo botanicals sensitive baby fragrance free diaper rash cream
SPL v1
SPL
SPL Set ID 186a9642-cd73-adfb-e063-6394a90a75c7
Route
topical
Published
Effective Date 2024-05-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (250 mg)
Inactive Ingredients
filipendula ulmaria flower shea butter chamomile nasturtium officinale flowering top cocoa butter calendula officinalis flower lecithin, sunflower rosemary coconut oil sunflower oil candelilla wax

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-06-01

Purpose

Skin Protectant

Description

Zinc Oxide 25%


Medication Information

Warnings

For external use only

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

Skin Protectant

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 Information
  • Protect this product from excessive heat and direct sun
  • May stain some fabrics and surfaces
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

Description

Zinc Oxide 25%

Active Ingredient

Zinc Oxide 25%

Product Packaging

Questions Or Comments?

Call 1-800-422-2987 M-F 9:00AM-5:00PM EST

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.


Structured Label Content

Warnings

For external use only

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

Skin Protectant

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 Information (Other information)
  • Protect this product from excessive heat and direct sun
  • May stain some fabrics and surfaces
Inactive Ingredients (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

Active Ingredient (Active ingredient)

Zinc Oxide 25%

Product Packaging

Questions Or Comments? (Questions or comments?)

Call 1-800-422-2987 M-F 9:00AM-5:00PM EST

When Using This Product (When using this product)
  • do not get into eyes
Stop Use and Ask Doctor If (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.


Advanced Ingredient Data


Raw Label Data

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