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.

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:

water, stearyl stearate, propylene glycol, cetyl alcohol, isopropyl myristate, sodium metabisulfite, fragrance, steareth 20, methylparaben, methyl alcohol, propylis gallas, sodium sulfite, tetrasodium EDTA, propylparaben, citric acid.

label image

ULTRA GLOW FADE 
hydroquinone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58318-003
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 1 g  in 51 g
Inactive Ingredients
Ingredient Name Strength
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 DITHIONATE (UNII: RPF7Z41GAW)  
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:58318-003-01 51 g in 1 CANISTER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part358A 04/07/1964
Labeler - Keystone Laboratories (007017429)
Establishment
Name Address ID/FEI Business Operations
Keystone Laboratories 007017429 manufacture(58318-003)

Revised: 11/2013
Document Id: a1ff198f-2caf-4435-b0cd-ae6f66f83e1e
Set id: 2557b4dc-2e85-4611-afed-c299f4ed3bbf
Version: 2
Effective Time: 20131114
 
Keystone Laboratories