NDC 73921-013 S-cream Zinc Oxide 13%

Zinc Oxide

NDC Product Code 73921-013

NDC Product Information

S-cream Zinc Oxide 13% with NDC 73921-013 is a a human over the counter drug product labeled by Global Pharma Healthcare Private Limited. The generic name of S-cream Zinc Oxide 13% is zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Global Pharma Healthcare Private Limited

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.

S-cream Zinc Oxide 13% 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 13 g/100g

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)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
  • MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
  • PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • TROPOLONE (UNII: 7L6DL16P1T)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)

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.

S-cream Zinc Oxide 13% Product Label Images

S-cream Zinc Oxide 13% 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

Zinc Oxide 13%

Purpose

Skin Protectant

Inactive Ingredients

Water, Mineral oil, Petrolatum, Beeswax, Dimethicone, Sorbitan sesquioleate, Microcrystalline wax, PEG-30 Dipolyhydroxystearate, Aloe barbadensis leaf extract, Glycerin, Tropolone, Tocopheryl acetate, 1,2-Hexanediol, Caprylyl glycol, Magnesium sulfate, Potassium hydroxide, Phenoxyethanol

Uses

• Helps treat and prevent diaper rash• Protects chafed skin due to diaper rash and helps seal out moisture • Insect bites • Burns minor abrasions • Skin irritation

Warnings

For external use onlyWhen using this productDo not get into eyesStop use and ask a doctor if• Condition worsens• Symptoms last 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 childrenIf swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Change wet and soiled diapers promptly• Cleanse the diaper area• Allow to dry• Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other Information

Store at 20° to 25°C (68°F to 77°F)Protect from freezingMay stain clothing

* Please review the disclaimer below.