NDC 49283-114 Glycolic Acid

Glycolic Acid

NDC Product Code 49283-114

NDC 49283-114-17

Package Description: 48 g in 1 BOTTLE

NDC Product Information

Glycolic Acid with NDC 49283-114 is a a human over the counter drug product labeled by Chemco Corporation. The generic name of Glycolic Acid is glycolic acid. The product's dosage form is cream and is administered via topical form.

Labeler Name: Chemco Corporation

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.

Glycolic Acid 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.

  • GLYCOLIC ACID 1.4 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.

  • PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
  • LIMONENE, (+/-)- (UNII: 9MC3I34447)
  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)
  • BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
  • CITRAL (UNII: T7EU0O9VPP)
  • COUMARIN (UNII: A4VZ22K1WT)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • MENTHOL (UNII: L7T10EIP3A)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • EUGENOL (UNII: 3T8H1794QW)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • SALIX ALBA BARK (UNII: 205MXS71H7)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

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: Chemco Corporation
Labeler Code: 49283
Marketing Category: UNAPPROVED DRUG OTHER - 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: 04-07-2021 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".

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Glycolic Acid Product Label Images