NDC 70605-037 Spotfade Dark Spot Wand

Hydroquinone

NDC Product Code 70605-037

NDC 70605-037-22

Package Description: 1 TUBE in 1 CARTON > 60 mL in 1 TUBE

NDC 70605-037-95

Package Description: 1 TUBE in 1 CARTON > 20 mL in 1 TUBE

NDC Product Information

Spotfade Dark Spot Wand with NDC 70605-037 is a a human over the counter drug product labeled by Guthy-renker Llc. The generic name of Spotfade Dark Spot Wand is hydroquinone. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Guthy-renker Llc

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.

Spotfade Dark Spot Wand 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.

  • HYDROQUINONE 20 g/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.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • OLIVE OIL GLYCERETH-8 ESTERS (UNII: 322K2STO13)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
  • ISOHEXADECANE (UNII: 918X1OUF1E)
  • HEXYLRESORCINOL (UNII: R9QTB5E82N)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • DULSE (UNII: 7832HOY4ZQ)
  • SODIUM SULFITE (UNII: VTK01UQK3G)
  • RETINOL (UNII: G2SH0XKK91)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • LAURETH-23 (UNII: N72LMW566G)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
  • TRIDECETH-6 PHOSPHATE (UNII: NKT96BX1OC)
  • CETYL PALMITATE (UNII: 5ZA2S6B08X)
  • CERAMIDE NP (UNII: 4370DF050B)
  • TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
  • 4-METHOXYBENZOYLOXYACETIC ACID (UNII: A6VXV872O8)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • 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.
  • 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: Guthy-renker Llc
Labeler Code: 70605
FDA Application Number: part358A 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 02-01-2020 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: 12-31-2021 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.

Spotfade Dark Spot Wand Product Label Images

Spotfade Dark Spot Wand 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

Other

Drug Fact Label

Children under 12 years of age: do not use unless directed by a doctor.

Adults: apply a small amount as thin layer on the affected area twice daily. Or use as directed by a doctor. If no improvement is seen after 3 months of treatment use of this product should be discontinued. Lightening effect of this product may not be noticeable when used on very dark skin.

DISTRIBUTED BY THE BODY FIRM, LLC, EL SEGUNDO, CA 90245

Active Ingredient

Hydroquinone 2%

Indications & Usage

Lightens dark spots

Warnings

For external use only

Otc - Do Not Use

  • Do not use on damaged or broken skin.

Otc - When Using

  • When using this productwhen using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

  • Stop use and ask a doctorif rash occurs.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.if swallowed, get medical help or contact a Poison Control Center right away.

Sunburn Alert

These products contain alpha hydroxy acids (AHAs) that may increase your skins sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using these products and for a week afterwards.

Inactive Ingredients

Water, Alcohol Denat., Glycerin, Olive Oil Glycerth 8 Esters, Niacinamide, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Hexylresorcinol, Pentylene Glycol, Palmaria Palmata Extract, Sodium Sulfite, BHA, Retinol, Hexylene Glycol, Ethylhexylglycerin, Caprylyl Glycol, Maltodextrin, Denatonium Benzoate, t-Butyl Alcohol, Glycolic Acid, Polysorbate 80, Sorbitan Oleate, Disodium EDTA, Sodium Metabisulfite, Phenoxyethanol.

* Please review the disclaimer below.