Your browser does not support JavaScript! ULTRA GLOW FADE (HYDROQUINONE) CREAM [KEYSTONE LABORATORIES]
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ULTRA GLOW FADE (hydroquinone) cream
[Keystone Laboratories]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:58318-003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE1 g  in 51 g
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERYL MONOSTEARATE 
SODIUM LAURYL SULFATE 
PROPYLENE GLYCOL 
ISOPROPYL MYRISTATE 
CETYL ALCOHOL 
SODIUM DITHIONATE 
STEARYL STEARATE 
STEARETH-20 
METHYLPARABEN 
PROPYLPARABEN 
BUTYLATED HYDROXYTOLUENE 
PROPYL GALLATE 
SODIUM SULFITE 
EDETATE DISODIUM 
CITRIC ACID MONOHYDRATE 
METHYL ALCOHOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58318-003-0151 g in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A04/07/1964
Labeler - Keystone Laboratories (007017429)
Establishment
NameAddressID/FEIBusiness Operations
Keystone Laboratories007017429manufacture(58318-003)

Revised: 11/2013
 
Keystone Laboratories

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