Label: ULTRA GLOW FADE WITH ALOE VERA- hydroquinone, padimate o cream
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Contains inactivated NDC Code(s)
NDC Code(s): 58318-002-01 - Packager: Keystone Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated November 18, 2013
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- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- INDICATIONS & USAGE
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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.
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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
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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
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INGREDIENTS AND APPEARANCE
ULTRA GLOW FADE WITH ALOE VERA
hydroquinone, padimate o creamProduct 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)
