NDC 72886-3066 Dr. Smarth Aloe Soft Vitamin Enriched

Zinc Oxide

NDC Product Code 72886-3066

NDC Product Information

Dr. Smarth Aloe Soft Vitamin Enriched with NDC 72886-3066 is a a human over the counter drug product labeled by Crystal Curam. The generic name of Dr. Smarth Aloe Soft Vitamin Enriched is zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Crystal Curam

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 Additional informationCallout TooltipWhat 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.


Dr. Smarth Aloe Soft Vitamin Enriched Active Ingredient(s)

Additional informationCallout TooltipWhat 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 3.8 g/100g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
  • CETETH-10 (UNII: LF9X1PN3XJ)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CHOLECALCIFEROL (UNII: 1C6V77QF41)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • LANOLIN (UNII: 7EV65EAW6H)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)
  • STEARETH-20 (UNII: L0Q8IK9E08)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • VITAMIN A (UNII: 81G40H8B0T)
  • WATER (UNII: 059QF0KO0R)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • D&C RED NO. 21 (UNII: 08744Z6JNY)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Crystal Curam
Labeler Code: 72886
FDA Application Number: part347 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-01-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Dr. Smarth Aloe Soft Vitamin Enriched Product Label Images

Dr. Smarth Aloe Soft Vitamin Enriched 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 (3.8%w/w)

Purpose

Skin Protectant

Uses

■ helps treat and prevent diaper rash ■ temporarily protects minor ■ cuts ■ scrapes ■ burns dries the oozing and weeping of: ■ Poison ivy ■ poison oak ■ poison sumac

Warnings

For external use only

When Using This Product

■ do not get into eyes

Stop Use And Ask A Doctor If

Conditions worsen symptoms last more than 7 days or clear up and occur again in a few days, consult a physician

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged ■ for poison ivy, oak and sumac ■ apply ointment liberally as needed

Other Information

■ store at room temperature 15-30C (59-86F) ■ avoid excessive heat

Inactive Ingredients

Aloe vera leaf, alpha-tocopherol, ceteth-10, cetostearyl alcohol, cetyl alcohol, cholecalciferol, glycerin, lanolin, lavender








methylparaben, mineral oil, paraffin, petrolatum, phenoxyethanol, polyethylene glycol 6000, polysorbate 60, propylparaben sodium








steareth-20, trolamine, vitamin A, water, FDC Yellow No.5, DC Red No.21

* Please review the disclaimer below.

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