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Pure Valley Miracle Age Spot

Dosage form: lotion
Ingredients: HYDROQUINONE 0.015g in 1g
Labeler: Concept Laboratories, Inc.
NDC Code: 64058-116

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Pure Valley® Miracle Age Spot

Drug Facts

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

Warnings

For external use only.

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

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

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

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

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

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

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

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

PURE VALLEY MIRACLE AGE SPOT 
hydroquinone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-116
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE 
CETOSTEARYL ALCOHOL 
POLYOXYL 20 CETOSTEARYL ETHER 
PETROLATUM 
MINERAL OIL 
ISOPROPYL MYRISTATE 
SHEA BUTTER 
GLYCERIN 
Water 
ASCORBIC ACID 
ANHYDROUS CITRIC ACID 
GLYCOLIC ACID 
DMDM HYDANTOIN 
PROPYLENE GLYCOL 
METHYLPARABEN 
PROPYLPARABEN 
EDETATE DISODIUM 
GLYCYRRHIZA GLABRA 
SODIUM METABISULFITE 
Packaging
#Item CodePackage Description
1NDC:64058-116-34113 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart358A10/01/2002
Labeler - Concept Laboratories, Inc. (962282612)
Establishment
NameAddressID/FEIOperations
Concept Laboratories, Inc.962282612MANUFACTURE(64058-116)

 
Concept Laboratories, Inc.

Medically reviewed on Oct 27, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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