ULTRA GLOW FADE WITH ALOE VERA- hydroquinone, padimate o 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

Active Ingredient: 2% Hydroquinone, 1.5% Padimate O

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PURPOSE

Skin lightener

INDICATIONS & USAGE

Ultra Glow Fade Cream with Aloe Vera

WARNINGS

Caution: Discontinue use of this product if skin irritation occurs or is already present. Do not use on children under 12 years of age. Avoid contact with eyes or consumption. Administer a patch test on a small area of the skin before applying cream to larger areas of the skin.

Precautions d'emploi: Cesser l'utilisation du produit en cas d'irritation ou sur une peau deja irritee. Ne pas appliquer sur les enfants de moins de 12 ans. Eviter le contact avec les yeux et ne pas avaler. Realiser un test sur une zone reduite de la peau avand d'appliquer la creme sur des zones plus etendues.

DOSAGE & ADMINISTRATION

Directions:Apply a small amount on the discolored or affected area twice daily. Results may vary; however, desired results are typically visibile within two weeks of usage. If no improvement is visible within 90 days of treatment, discontinue use of this product.

Conseils d'application: Pour un maximum de resultat, appliquer une petite quantite de creme deux foix par jour sur les zones decolorees ou abimees. Les resultats peuvent varier et sont en general visibles apres deux semaines d'utilisation. En l'absence d'ameliorations visibles dans les 90 jours de traitement, interrompre l'application du produit.

OTHER SAFETY INFORMATION

KEYSTONE LABORATORIES © 2012

www.keystone-labs.com

1-800-772-8860

Memphis, TN 38101-2026

NW7 3SA London, United Kingdom

MADE IN U.S.A. / FABRIQUE AUX E.-U.

PM-TB 0028

INACTIVE INGREDIENT

Other Ingredients:

aqua/water/eau, stearyl steareth, glycerol stearate, propylene glycol, cetyl alcohol, isopropyl myristate, ethylhexyl dimethyl, paraffinum liquidum/mineral oil/huile minerale, sodium metabisulfite, fragrance, steareth 20, methylparaben, tetrsodium edta, sodium sulfite, propylis gallas, methyl alcohol, propylparaben, citric acid, aloe barbadensis (leaf juice).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ULTRA GLOW FADE  WITH ALOE VERA
hydroquinone, padimate o cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58318-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	1 g  in 57 g
PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ)	PADIMATE O	1 g  in 57 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)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58318-002-01	57 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(58318-002)