NDC 54111-113 Yes To Coconut

Allantoin

NDC Product Code 54111-113

NDC 54111-113-50

Package Description: 85 mL in 1 TUBE

NDC Product Information

Yes To Coconut with NDC 54111-113 is a a human over the counter drug product labeled by Bentley Laboratories, Llc. The generic name of Yes To Coconut is allantoin. The product's dosage form is cream and is administered via topical form.

Labeler Name: Bentley Laboratories, Llc

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.

Yes To Coconut 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.

  • ALLANTOIN .425 g/85mL

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.

  • WATER (UNII: 059QF0KO0R)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • AVOCADO OIL (UNII: 6VNO72PFC1)
  • JOJOBA OIL (UNII: 724GKU717M)
  • ALMOND OIL (UNII: 66YXD4DKO9)
  • SESAME OIL (UNII: QX10HYY4QV)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • BANANA (UNII: 4AJZ4765R9)
  • GUAVA (UNII: 74O70D6VG0)
  • ORCHIS MASCULA FLOWER (UNII: 6H1JQK35LA)
  • KUKUI NUT (UNII: J87WJ3E7VW)
  • HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)
  • NONI FRUIT (UNII: 7829X3G2X5)
  • CITRUS MAXIMA SEED (UNII: 083X55C543)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

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.

Product Labeler Information

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

Labeler Name: Bentley Laboratories, Llc
Labeler Code: 54111
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: 05-05-2014 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Yes To Coconut Product Label Images

Yes To Coconut 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

Active Ingredient

DRUG FACTSActive IngredientAllantoin 0.50%

Purpose

Skin Protectant

Keep Out Of Reach Of Children

Keep out of reach of children: if swallowed, get medical help or contact a Poison Control Center immediately.

Uses:

Helps prevent and temporarily protects chafed, chapped, or cracked skin

Warnings:

For external use only

Do Not Use

On broke or damaged skin

When Using This Product

Avoid contact with eyes. If contact occurs, rinse with water to remove.

Stop Use And Ask A Doctor

If rash or irritation develops and lasts.

Directions:

Apply to hands twice a day.

Inactive Ingredients

Water (Aqua), Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, Caprylic/Capric Triglyceride, Isopropyll Myristate, Glycerin, Stearic Acid, Stearyl Alcohol, Polyglyceryl-10 Laurate, Cocos Nucifera (Coconut Oil), Persea Grattisima (Avocado) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Calendula Officinalis Flower Extract, Musa Sanientum (Banana) Fruit Extract, Psidium Guaiava Fruit Extract, Orchis Mascula Flower Extract, Aleurites Moluccana Seed Extract, Citrus Grandis (Grapefruit) Seed Extract, Tocopheyl Acetate, Polyglyceryl-3 Sterate, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate, Citric Acid, Ascorbic Acid, Sodium Hydroxide, Fragrance.

Other Information

Protect the product in this container from excessive heat and direct sun.

Questions?

1-888-92-Yes-To (1-888-929-3786) or visit www.yestocarrots.com

Yes To Product Label

HELPS PROTECT CRACKED SKINYES to®coconutHYDRATE and RESTOREprotectingHAND and CUTICLE CREAMYes to™ coconut oil and shea butter to help soften your hands, for more hand-holding.paraben-freeNatural 97% Product3 fl oz / 85 mLYes to™ coconut natural formulations combine oil from the hydrating, fatty acid rich Coconut fruit and other non-greasy moisturizers to help smooth dry cracked skin. Use the entire collection to hydrate and help restore skin ti its natural gorgeousness. Learn more about this collection at yestocarrots.comManufactured for Yes To Inc. San Francisco, CA 94107 USAYes to™ is a trademark of Yes To, Inc.YES to.   WITH LOVE FROM CALIFORNIA    YES TO SEED FUND    CRUELTY FREE

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