NDC 73921-036 L-topical Calamine 8% Pramoxine Hcl 1%

Calamine, Pramoxine Hydrochloride

NDC Product Code 73921-036

NDC CODE: 73921-036

Proprietary Name: L-topical Calamine 8% Pramoxine Hcl 1% 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: Calamine, Pramoxine Hydrochloride 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.

NDC Code Structure

  • 73921 - Global Pharma Healthcare Private Limited
    • 73921-036 - L-topical Calamine 8% Pramoxine Hcl 1%

NDC 73921-036-04

Package Description: 118 mL in 1 CONTAINER

NDC Product Information

L-topical Calamine 8% Pramoxine Hcl 1% with NDC 73921-036 is a a human over the counter drug product labeled by Global Pharma Healthcare Private Limited. The generic name of L-topical Calamine 8% Pramoxine Hcl 1% is calamine, pramoxine hydrochloride. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Global Pharma Healthcare Private Limited

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.

L-topical Calamine 8% Pramoxine Hcl 1% 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 80 mg/mL

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.

  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)

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: Global Pharma Healthcare Private Limited
Labeler Code: 73921
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: 04-01-2021 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: 12-31-2022 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".

* Please review the disclaimer below.

L-topical Calamine 8% Pramoxine Hcl 1% Product Label Images

L-topical Calamine 8% Pramoxine Hcl 1% 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

Calamine 8%Pramoxine HCl 1%


Skin protectantTopical analgesic


• Temporarily relieves pain and itching associated with:• Rashes due to poison ivy, • Poison oak or poison sumac • Insect bites • Minor skin irritation • Minor cuts • Dries the oozing and weeping of poison ivy, poison oak and poison sumac


For external use only.When using this product do not get into eyesStop use and ask a doctor if• Condition worsens or does not improve within 7 days• Symptoms persist for more than 7 days or 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.


• Shake well before use • 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: ask a doctor

Other Information

Store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

SD Alcohol 38-B, Camphor, Diazolidinyl urea, Fragrance, Hypromellose, Methylparaben, Polysorbate 80, Propylene glycol, Propylparaben, Purified water, Xanthan gum

* Please review the disclaimer below.