NDC 79265-8566 Babo Fragrance Free Diaper Cream

Zinc Oxide

NDC Product Code 79265-8566

NDC Product Information

Babo Fragrance Free Diaper Cream with NDC 79265-8566 is a a human over the counter drug product labeled by Babo Botanicals, Inc.. The generic name of Babo Fragrance Free Diaper Cream is zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Babo Botanicals, Inc.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Babo Fragrance Free Diaper Cream Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ZINC OXIDE 25 g/100g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • CANDELILLA WAX (UNII: WL0328HX19)
  • FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G)
  • ROSEMARY (UNII: IJ67X351P9)
  • COCOA BUTTER (UNII: 512OYT1CRR)
  • CHAMOMILE (UNII: FGL3685T2X)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • CORN OIL (UNII: 8470G57WFM)
  • LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • GLYCERIN (UNII: PDC6A3C0OX)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Babo Botanicals, Inc.
Labeler Code: 79265
FDA Application Number: part347 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 08-26-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Babo Fragrance Free Diaper Cream Product Label Images

Babo Fragrance Free Diaper Cream Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Babo Fragrance Free Diaper Cream

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

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.

Otc - When Using

When using this product avoid contact with eyes

Otc - Stop Use

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

Otc - Keep Out Of Reach Of Children

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

BUTYROSPERMUM PARKII (SHEA) BUTTER, CALENDULA OFFICINALIS FLOWER EXTRACT*, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*, COCOS NUCIFERA (COCONUT) OIL, EUPHORBIA CERIFERA (CANDELILLA) WAX, 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

* Please review the disclaimer below.