ULTRA GLOW FADE- hydroquinone cream 
Keystone Laboratories

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.

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2% Hydroquinone ..... Skin Lightener

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

Skin lightener

Ultra Glow Fade Cream

2% Hydroquinone  ......  Skin Lightener

Warnings:

For external use only. Children under 12 years of age: Do not use unless directed by a doctor. Some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor. Avoid contact with eyes, rinse with water to remove. Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin during and after treatment is completed in order to prevent darkening from reoccurring. 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 in a thin layer on the affected area twice daily or 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 on very dark skin.

Other Information: Protect the product in this container from excessive heat and direct sun. For expiration date, please see bottom of jar.

Distributed by 

KEYSTONE LABORATORIES © 2013

www.keystone-labs.com

1-800-772-8860  / Memphis, TN 38101-2026

MADE IN U.S.A.

PM-LB 0011

Inactive Ingredients:

Aqua/Water/Eau, Stearyl Stearate, Glycerol Stearate, Propylene Glycol Alcohol, Isopropyl Myristate, Sodium Metabisulfite, Fragrance, Sodium Sulfite, Steareth 20, Methyl Paraben, Buthydroxytoluene, Propyl Gallate, Tetrasodium EDTA, Propyl Paraben, Citric Acid

label

ULTRA GLOW FADE 
hydroquinone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58318-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE1 g  in 51 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
STEARYL STEARATE (UNII: 5WX2EGD0DK)  
STEARETH-20 (UNII: L0Q8IK9E08)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
SODIUM SULFITE (UNII: VTK01UQK3G)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYL ALCOHOL (UNII: Y4S76JWI15)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58318-003-0151 g in 1 CANISTER; Type 0: Not a Combination Product01/10/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A01/10/2018
Labeler - Keystone Laboratories (007017429)
Establishment
NameAddressID/FEIBusiness Operations
Keystone Laboratories007017429manufacture(58318-003)

Revised: 1/2018
Document Id: 626f5f92-05e4-5924-e053-2a91aa0ac58c
Set id: 2557b4dc-2e85-4611-afed-c299f4ed3bbf
Version: 5
Effective Time: 20180110
 
Keystone Laboratories