ULTRA GLOW FADE- hydroquinone cream

Ultra Glow Fade by

Drug Labeling and Warnings

Ultra Glow Fade by is a Otc medication manufactured, distributed, or labeled by Keystone Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

2% Hydroquinone ..... Skin Lightener

1.5% Padimate O.......Subscreen

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PURPOSE

Skin lightener

INDICATIONS & USAGE

Skin Lightener

Sunscreen

WARNINGS

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.

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

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 INGREDIENT

Inactive Ingredients:

water, stearyl stearate, propylene glycol, cetyl alcohol, isopropyl myristate, mineral oil, sodium metabisulfite, fragrance, steareth 20, methylparaben, butylhydoxytoluene, prophyl gallate, sodium sulfite, sodium sulfite, tetrasodium EDTA, propylparaben, citric acid, aloe barbadensis (Leaf Juice)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ULTRA GLOW FADE 
hydroquinone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58318-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	2 g  in 102 g
PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ)	PADIMATE O	1.5 g  in 102 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 METABISULFITE (UNII: 4VON5FNS3C)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYL ALCOHOL (UNII: Y4S76JWI15)
SODIUM SULFITE (UNII: VTK01UQK3G)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58318-008-01	102 g in 1 JAR; Type 0: Not a Combination Product	01/04/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part358A	01/04/2018

Labeler - Keystone Laboratories (007017429)

Establishment
Name	Address	ID/FEI	Business Operations
Keystone Laboratories		007017429	manufacture(58318-008)