Pure Valley Miracle Age Spot
FDA Label NDC 64058-116

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Concept Laboratories, Inc. for the product Pure Valley Miracle Age Spot (NDC 64058-116). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, otc - stop use, otc - do not use, otc - pregnancy or breast feeding, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

For external use only.

  • avoid contact with eyes. If eye contact occurs flush thoroughly with water.

    • Manufactured by Concept Laboratories, Inc., Chicago, IL 60642 (USA)

Active Ingredient

Hydroquinone 1.5%

Purpose

Skin Lightener

Uses

for the gradual fading of dark (brownish) discolorations in the skin such as

  • freckles
  • age and liver spots
  • pigment in the skin that may occur in pregnancy or from the use of oral contraceptives

Otc - Stop Use

  • some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor

Otc - Do Not Use

  • do not use on children under 12 years of age unless directed by a doctor

Otc - Pregnancy Or Breast Feeding

  • if pregnant or nursing, seek the advice of a health professional before using

Otc - When Using

When using this product do not use on cracked, irritated or inflamed skin

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

Directions

  • Adults: apply a small amount as a 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.
  • for sensitive skin, test product on a small section of your skin inside your elbow

Inactive Ingredients

Water (Aqua), Glyceryl Stearate SE, Cetearyl Alcohol, Mineral Oil, Ceteareth-20, Isopropyl Myristate, Glycerin, Petrolatum, Butyrospermum Parkii (Shea Butter), Sodium Metabisulfite, Propylene Glycol, DMDM Hydantoin, Methylparaben, Propylparaben, Citric Acid, Glycolic Acid, Ascorbic Acid, Glycyrrhiza Glabra (Licorice) Root Extract, Disodium EDTA, Fragrance.

Other Information

  • For sensitive skin, test product on a small section of your skin inside your elbow. If no irritation develops after 24 hours proceed with application.
  • Close product lid tightly after each use. Cream may darken when exposed to air. Product performance will not be affected.
  • Do not use this product in combination with externally applied products containing resorcinol, phenol, salicylic acid or any type of acne product unless directed by a doctor.
  • Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.

Questions Or Comments?

Call 1-888-373-8831 or visit www.conceptlabs.org

Principal Display Panel - 113 G Jar Label

PURE VALLEY®

Miracle–Age Spot

FADE CREME

Skin Lightening

with Alpha Hydroxy Acids & Shea Butter

4oz. (113g)e

Principal Display Panel (113 g Jar Label)

Principal Display Panel (113 g Jar Label)

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