AMBI Fade description, usages, side effects, indications, overdosage, supplying and lots more!

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AMBI Fade

Valeant Pharmaceuticals North America LLC

AMBI Fade Cream - Normal Skin


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredients

Hydroquinone (2%)

Octinoxate (2%)

Purpose

Skin Bleaching Agent

Sunscreen

AMBI Fade Uses

  • •For the gradual fading of dark (brownish) skin discolorations such as freckles, age and liver spots or pigment that may occur in pregnancy or from the use of oral contraceptives.
  • •Contains a sunscreen to help prevent darkening from reoccurring.

Warnings

For external use only.

When using this product

  • •Avoid contact with eyes
  • •Some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor.

Do not use

  • •On children under 12 years of age unless directed by a doctor.
  • •This product is not for use in the prevention of sunburn.

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 as a thin layer on the affected area twice daily, or use 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 when used on very dark skin.
  • Children under 12 years of age: do not use unless directed by a doctor.
  • •Sun exposure should be limited by using a sunscreen agent or protective clothing to cover bleached skin after treatment is completed to prevent darkening from reoccurring.

Other Information

Store at room temperature.

Inactive Ingredients

Water, Glycerin, Isopropyl Myristate, Stearic Acid, Cyclopentasiloxane, Cetyl Alcohol, Betaine, Hydroxyethyl Urea, Glyceryl Stearate, PEG-100 Stearate, Potassium Cetyl Phosphate, Dimethicone Crosspolymer, Sodium Metabisulfite, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Fragrance, Tocopheryl Acetate, Methylparaben, Disodium EDTA, Lactic Acid, Propylparaben, Ethylparaben, PEG-16 Soy Sterol, Sodium Ascorbyl Phosphate, Butylene Glycol, Glycine Soja (Soybean) Protein

Questions/Comments?

1-800-321-4576

Package/Label Principal Display Panel

AMBI®

SKINCARE

Fade Cream

Fades dark spots for even, natural skin tone

With Vitamin E and Alpha Hydroxy Acid

NORMAL SKIN

NET WT. 2 OZ. (56g)

AMBI Fade

Hydroquinone and Octinoxate CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0187-5479
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Hydroquinone HYDROQUINONE 20 mg
OCTINOXATE OCTINOXATE 20 mg

Inactive Ingredients

Ingredient Name Strength
water
GLYCERIN
ISOPROPYL MYRISTATE
STEARIC ACID
CYCLOMETHICONE 5
CETYL ALCOHOL
BETAINE
HYDROXYETHYL UREA
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
potassium cetyl phosphate
SODIUM METABISULFITE
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)
.ALPHA.-TOCOPHEROL ACETATE
METHYLPARABEN
EDETATE DISODIUM
LACTIC ACID
PROPYLPARABEN
ETHYLPARABEN
SODIUM ASCORBYL PHOSPHATE
BUTYLENE GLYCOL
SOYBEAN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 56 in 1 TUBE
2 56 in 1 TUBE
3 3 in 1 TUBE
4 NDC:0187-5479-30 24 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partA part358A 2014-02-04


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