NDC 24286-1576 Earths Care Anti-itch

Camphor (natural) And Menthol, Unspecified Form

NDC Product Code 24286-1576

NDC 24286-1576-8

Package Description: 237 mL in 1 BOTTLE, PUMP

NDC Product Information

Earths Care Anti-itch with NDC 24286-1576 is a a human over the counter drug product labeled by Dlc Laboratories, Inc.. The generic name of Earths Care Anti-itch is camphor (natural) and menthol, unspecified form. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Dlc Laboratories, Inc.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Earths Care Anti-itch 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.

  • CAMPHOR (NATURAL) .5 g/100mL
  • MENTHOL, UNSPECIFIED FORM 1 g/100mL

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)
  • GINGER (UNII: C5529G5JPQ)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ALMOND OIL (UNII: 66YXD4DKO9)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
  • TRICAPRILIN (UNII: 6P92858988)
  • TRICAPRIN (UNII: O1PB8EU98M)
  • JOJOBA OIL (UNII: 724GKU717M)
  • AVOCADO OIL (UNII: 6VNO72PFC1)
  • .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
  • ARGAN OIL (UNII: 4V59G5UW9X)
  • OATMEAL (UNII: 8PI54V663Y)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • TOCOPHEROL (UNII: R0ZB2556P8)

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: Dlc Laboratories, Inc.
Labeler Code: 24286
FDA Application Number: part348 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 08-28-2020 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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Earths Care Anti-itch Product Label Images

Earths Care Anti-itch 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

Other

Drug Facts

Otc - Purpose

Active ingredientsPurposeCamphor 0.5%External analgesicMenthol 1%External analgesic

Uses

For the temporary relief of pain and itching associated with minor skin irritations such as poison ivy/oak/sumac, sunburn, insect bites, and minor cuts and scrapes.

Warnings

  • For external use only

When Using This Product

  • Avoid contact with eyes

Stop Use And Ask A Doctor If

  • Condition worsenssymptoms persist for more than 7 days or clear up and occur again within a few days

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Distributed by:Earth's Care Natural Products, Inc.Long Beach, California 90805 USA

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

  • Adults and children 2 years of age and older:apply to affected area not more than 3 to 4 times daily.Children under 2 years of age: consult a doctor.

Inactive Ingredients

Aloe vera (Aloe barbadensis) extract, alpha-bisabolol, argan (Argania spinosa) kernel oil, avocado (Persea gratissima) oil, Butyrospermum parkii (shea) butter, caprylic/capric triglyceride, cetyl alcohol, cetyl hydroxyethylcellulose, colloidal oatmeal, ethylhexylglycerin, ginger (Zingiber officinale) root extract, glycerin, glyceryl stearate, heptyl undecylenate, jojoba (Simmondsia chinensis) seed oil, phenoxyethanol, polyglyceryl-3 dicitrate/stearate, potassium hydroxide, Prunus amygdalus dulcis (sweet almond) oil, purified water, tocopherol (natural vitamin E)

Questions

1-888-602-6380

* Please review the disclaimer below.