Babo Botanicals Soothing Diaper Cream 3 oz

Babo Soothing Diaper Cream by

Drug Labeling and Warnings

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

Drug Details [pdf]

BABO SOOTHING DIAPER CREAM- zinc oxide cream 
Babo Botanicals, Inc.

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Babo Botanicals Soothing Diaper Cream 3 oz

Babo Botanicals Soothing Diaper Cream (79265-9606-3)

This is a diaper rash cream manufactured according to the Final Monograph for Skin Protectants with 25% Zinc Oxide.

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.

When using this product avoid contact with eyes

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

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

AVENA SATIVA (OAT) KERNEL EXTRACT, BUTYROSPERMUM PARKII (SHEA) BUTTER, CALENDULA OFFICINALIS FLOWER EXTRACT*, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*, COCOS NUCIFERA (COCONUT) OIL, EUPHORBIA CERIFERA (CANDELILLA) WAX, FRAGRANCE (NATURAL), 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: 79265-9606-3

79265-9606 Outer Packaging

BABO SOOTHING DIAPER CREAM 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 79265-9606
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LINALOOL, (+/-)- (UNII: D81QY6I88E) 0.000125 g  in 100 g
ROSEMARY (UNII: IJ67X351P9) 0.25 g  in 100 g
ISOEUGENOL (UNII: 5M0MWY797U) 0.000125 g  in 100 g
GERANIOL (UNII: L837108USY) 0.000125 g  in 100 g
CORN OIL (UNII: 8470G57WFM) 10 g  in 100 g
NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G) 0.001 g  in 100 g
CANANGA OIL (UNII: 8YOY78GNNX) 0.000125 g  in 100 g
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) 0.25 g  in 100 g
CITRAL (UNII: T7EU0O9VPP) 0.000125 g  in 100 g
OAT (UNII: Z6J799EAJK) 0.001 g  in 100 g
SHEA BUTTER (UNII: K49155WL9Y) 5 g  in 100 g
COCOA BUTTER (UNII: 512OYT1CRR) 0.75 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 0.001 g  in 100 g
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) 0.001 g  in 100 g
FARNESOL (UNII: EB41QIU6JL) 0.000125 g  in 100 g
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6) 0.001 g  in 100 g
LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.000125 g  in 100 g
EUGENOL (UNII: 3T8H1794QW) 0.000125 g  in 100 g
CHAMOMILE (UNII: FGL3685T2X) 0.001 g  in 100 g
COCONUT OIL (UNII: Q9L0O73W7L) 10 g  in 100 g
CANDELILLA WAX (UNII: WL0328HX19) 5 g  in 100 g
SUNFLOWER OIL (UNII: 3W1JG795YI) 43.743 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 79265-9606-385 g in 1 TUBE; Type 0: Not a Combination Product08/26/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01608/26/202010/23/2023
Labeler - Babo Botanicals, Inc. (058258734)

Revised: 10/2023
 

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