BABO FRAGRANCE FREE DIAPER CREAM- zinc oxide cream

Babo Fragrance Free Diaper Cream by

Drug Labeling and Warnings

Babo Fragrance Free Diaper Cream by is a Otc medication manufactured, distributed, or labeled by Babo Botanicals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Zinc Oxide 25%

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

• 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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

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) EXTRACT*, COCOS NUCIFERA (COCONUT) OIL*, EUPHORBIA CERIFERA (CANDELILLA) WAX, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, HYDROGENATED VEGETABLE OIL, LECITHIN, NASTURTIUM OFFICINALE (WATERCRESS) LEAF EXTRACT*, ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT*, SPIRAEA ULMARIA (MEADOWSWEET) EXTRACT*, THEOBROMA CACAO (COCOA) SEED BUTTER*

*Certified Organic Ingredients

Questions or comments?

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

Product Packaging

INGREDIENTS AND APPEARANCE

BABO FRAGRANCE FREE DIAPER CREAM 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79265-8566
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)	0.001 g  in 100 g
CANDELILLA WAX (UNII: WL0328HX19)	5 g  in 100 g
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)	0.001 g  in 100 g
SHEA BUTTER (UNII: K49155WL9Y)	5 g  in 100 g
NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G)	0.001 g  in 100 g
ROSEMARY (UNII: IJ67X351P9)	0.25 g  in 100 g
COCOA BUTTER (UNII: 512OYT1CRR)	0.75 g  in 100 g
CHAMOMILE (UNII: FGL3685T2X)	0.001 g  in 100 g
SUNFLOWER OIL (UNII: 3W1JG795YI)	43.744 g  in 100 g
CORN OIL (UNII: 8470G57WFM)	10 g  in 100 g
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)	0.25 g  in 100 g
COCONUT OIL (UNII: Q9L0O73W7L)	10 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	0.002 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79265-8566-3	85 g in 1 TUBE; Type 0: Not a Combination Product	08/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	08/26/2020

Labeler - Babo Botanicals, Inc. (058258734)