Label: ULTRA GLOW FADE- hydroquinone cream
- NDC Code(s): 58318-003-01
- Packager: Keystone Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- ACTIVE INGREDIENT
2% Hydroquinone ..... Skin LightenerClose
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children.Close
- INDICATIONS & USAGE
Ultra Glow Fade Cream
2% Hydroquinone ...... Skin LightenerClose
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.Close
- DOSAGE & ADMINISTRATION
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.Close
- 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.
KEYSTONE LABORATORIES © 2013
1-800-772-8860 / Memphis, TN 38101-2026
MADE IN U.S.A.
- INACTIVE INGREDIENT
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.Close
- INGREDIENTS AND APPEARANCE
ULTRA GLOW FADE
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)