NDC 10742-7010 Softlips Peppermint Mocha, Apple Chai Cider, Orange Cranberry

Dimethicone, Octinoxate, Octisalate, Oxybenzone

NDC Product Code 10742-7010

NDC CODE: 10742-7010

Proprietary Name: Softlips Peppermint Mocha, Apple Chai Cider, Orange Cranberry What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Dimethicone, Octinoxate, Octisalate, Oxybenzone What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used as a moisturizer to treat or prevent dry, rough, scaly, itchy skin and minor skin irritations (e.g., diaper rash, skin burns from radiation therapy). Emollients are substances that soften and moisturize the skin and decrease itching and flaking. Some products (e.g., zinc oxide, white petrolatum) are used mostly to protect the skin against irritation (e.g., from wetness). Dry skin is caused by a loss of water in the upper layer of the skin. Emollients/moisturizers work by forming an oily layer on the top of the skin that traps water in the skin. Petrolatum, lanolin, mineral oil and dimethicone are common emollients. Humectants, including glycerin, lecithin, and propylene glycol, draw water into the outer layer of skin. Many products also have ingredients that soften the horny substance (keratin) that holds the top layer of skin cells together (e.g., urea, alpha hydroxy acids such as lactic/citric/glycolic acid, and allantoin). This helps the dead skin cells fall off, helps the skin keep in more water, and leaves the skin feeling smoother and softer.

NDC Code Structure

  • 10742 - The Mentholatum Company

NDC 10742-7010-1

Package Description: 3 TUBE in 1 BLISTER PACK > 2 g in 1 TUBE

NDC Product Information

Softlips Peppermint Mocha, Apple Chai Cider, Orange Cranberry with NDC 10742-7010 is a a human over the counter drug product labeled by The Mentholatum Company. The generic name of Softlips Peppermint Mocha, Apple Chai Cider, Orange Cranberry is dimethicone, octinoxate, octisalate, oxybenzone. The product's dosage form is stick and is administered via topical form.

Labeler Name: The Mentholatum Company

Dosage Form: Stick - A dosage form prepared in a relatively long and slender often cylindrical form.

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.

Softlips Peppermint Mocha, Apple Chai Cider, Orange Cranberry 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.

  • DIMETHICONE 20 mg/g
  • OCTINOXATE 75 mg/g
  • OCTISALATE 30 mg/g
  • OXYBENZONE 30 mg/g

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.

  • CERESIN (UNII: Q1LS2UJO3A)
  • SQUALANE (UNII: GW89575KF9)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
  • MYRISTYL LACTATE (UNII: 1D822OC34X)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • MYRISTYL LAURATE (UNII: 58U0NZN2BT)
  • MYRISTYL ALCOHOL (UNII: V42034O9PU)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
  • .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)

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: The Mentholatum Company
Labeler Code: 10742
FDA Application Number: part352 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: 11-09-2020 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’.

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Softlips Peppermint Mocha, Apple Chai Cider, Orange Cranberry Product Label Images

Softlips Peppermint Mocha, Apple Chai Cider, Orange Cranberry 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 Ingredients

Dimethicone 2%Octinoxate 7.5%Octisalate 3%Oxybenzone 3%

Purpose

Dimethicone - Skin protectantOctinoxate – SunscreenOctisalate – SunscreenOxybenzone - Sunscreen

Uses

  • •helps prevent sunburn •temporarily protects chapped or cracked lips

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.For external use onlyDo not use on damaged or broken skin

When Using This Product

Keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor If

  • •rash occurs •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 right away.

Directions

  • •apply liberally 15 minutes before sun exposure •use a water resistant sunscreen if swimming or sweating •reapply at least every 2 hours •children under 6 months: ask a doctor

Other Safety Information

  • •protect this product from excessive heat and direct sun

Inactive Ingredients

Ozokerite, squalane, ethylhexyl palmitate, petrolatum, myristyl myristate, myristyl lactate, flavor, cetyl alcohol, myristyl laurate, myristyl alcohol, BHT, menthol, tocopheryl acetatate [vitamin E]

Questions?

1-877-636-2677 MON-FRI 9 AM to 5 PM (EST) softlips.com

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