NDC 0904-7760 Clear Anti Itch

Pramoxine Hcl, Zinc Acetate

NDC Product Code 0904-7760

NDC 0904-7760-21

Package Description: 177 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Clear Anti Itch with NDC 0904-7760 is a a human over the counter drug product labeled by Major Pharmaceuticals. The generic name of Clear Anti Itch is pramoxine hcl, zinc acetate. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Major Pharmaceuticals

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.

Clear 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.

  • PRAMOXINE HYDROCHLORIDE 10 mg/mL
  • ZINC ACETATE 1 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)
  • CAMPHOR (NATURAL) (UNII: N20HL7Q941)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDROXYPROLINE (UNII: RMB44WO89X)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • ROSEMARY OIL (UNII: 8LGU7VM393)
  • POLYSORBATE 40 (UNII: STI11B5A2X)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)

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: Major Pharmaceuticals
Labeler Code: 0904
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: 04-18-1995 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: 12-31-2020 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.

Clear Anti Itch Product Label Images

Clear 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

Active Ingredients

Pramoxind HCl 1%Zinc acetate 0.1%

Purpose

External analgesicSkin protectant

Use

  • For the temporary relief oc pain and itching associated with minor skin irritations and rashes due to poison ivy, poison oak or poison sumacdries the oozing and weeping of poison: ivyoaksumac

Warnings

For external use only

When Using This Product

Do not get into eyes

Stop Use And Ask A Doctor If

  • Condition worsenssymptoms 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

  • Shake wellbefore applying was affected are of skinadults and children 2 years of age and older - apply to affected area not more than 3 to 4 times dailychildren under 2 years of age - ask a doctor

Other Information

Store at room temperature (59°-77°F)

Inactive Ingredients

Alcohol, caphor, citric acid, diazolidinyl urea, fragrance, glycerin, hydroxypropyl metylcelluloe, methylparaben, oil of lavender, oil of rosemary, polysorbate 40, propylene glycol, propylparaben, purified water, sodium citrate

Adverse Reactions

Distributed ByMAJOR PHARMACEUTICALS31778 ENTERPRISE DRIVELIVONIA, MI 48150SERIOUS SIDE EFFECTS ASSOCIATEDWITH USE OF THIS PRODUCT MAY BEREPORTED TO: 1-800-616-2471

Disclaimer

This product is not manufactured or distributed by Pfizer Consumer HealthCare, distributor of Caladryl Clear Lotion

* Please review the disclaimer below.