NDC 72663-069 Welly Calm Balm

Anti Itch Cream

NDC Product Code 72663-069

NDC Product Information

Welly Calm Balm with NDC 72663-069 is a a human over the counter drug product labeled by Welly Health Pbc. The generic name of Welly Calm Balm is anti itch cream. The product's dosage form is cream and is administered via topical form.

Labeler Name: Welly Health Pbc

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.


Welly Calm Balm 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.

  • DIPHENHYDRAMINE HYDROCHLORIDE 20 mg/g
  • ZINC ACETATE 1 mg/g

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.

  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)

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: Welly Health Pbc
Labeler Code: 72663
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: 02-09-2019 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.

Welly Calm Balm Product Label Images

Welly Calm Balm 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

Diphenhydramine hydrochloride 2%Zinc Acetate 0.1%

Purpose

Topical analgesicSkin protectant

Uses

  • For temporary relief from pain and itching associated with :insect bitesminor burnssunburnminor skin irritationsrashes due to poison ivy, poison oak, and poison sumacDries the oozing and weeping of poisonivyoaksumac

Warnings

  • For external use onlyDo not use on large areas of the bodywith any other product containing diphenhydramine , even one taken by the mouth.Ask a Doctor before useon chicken poxon measlesWhen using this product avoid contact with eyes.Stop use and ask a doctor ifconditions worsen or does not improve within 7 dayssymptoms persist for more than 7 days or clear up and occur agian within a few days

Keep This And All Drugs Out Of The Reach Of Children.

If swallowed get medical help or contact a Poison Control Center immediately.

Directions

  • Do not use more than directedadults and children 2 years of age and older; apply to affected areas not more than 3 to 4 times dailychildren under 2 years of age , consult a doctorOther Information Store at controlled room temperature 20°-25°C (68° - 77°F)Close the cap tightly after use

Inactive Ingredients

Cetyl Alcohol, Citric Acid, Diazolldinyl Urea, Glyceryl Sterate, Methylparaben, Polyethylene Glycol Monosterate  1000, Propylene Glycol, Propylparaben, Sodium Citrate , Purified Water

* Please review the disclaimer below.

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