Ambi Acne Spot Treatment description, usages, side effects, indications, overdosage, supplying and lots more!

Ambi Acne Spot Treatment

Valeant Pharmaceuticals North America LLC

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
AMBI Even & Clear Acne Spot Treatment

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredient

Benzoyl Peroxide 5%

Purpose

Acne Treatment

Use

For the treatment of acne.

Warnings

For external use only

Do not use if you are sensitive to Benzoyl Peroxide or have very sensitive skin. This product may cause irritation. If excess irritation occurs, discontinue use.

Ask a doctor or pharmacist before use if you are using any topical acne drugs at the same time or right after use of this product. This may cause irritation, characterized by redness, burning, itching, peeling, or possibly swelling. Mild irritation may be reduced by using the product less frequently or in a lower concentration. If irritation becomes severe, discontinue use. If irritation still continues, consult a doctor.

When using this product

  • Avoid contact with eyes. If contact occurs, flush thoroughly with water.
  • Keep away from lips and mouth
  • Avoid unnecessary sun exposure and use a sunscreen
  • Avoid product contact with hair and dyed fabrics, including carpets and clothing which may be bleached by this product.

Stop use and ask a doctor if excess irritation occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Wash skin thoroughly and dry.
  • Apply directly on blemishes.
  • Apply one a day intially, then 2 to 3 times daily. If dryness or mild peeling occurs, reduce application to once a day, as needed.

Inactive ingredients

Water, Glycerin, Methylpropanediol, Acryaltes/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Sodium Hydroxide, Sodium Benzoate, Bisabolol, Ethylhexylglycerin, Tetrasodium EDTA, Butylene Glycol, Chamomilla Recutita (Matricaria) Flower Extract, Sea Whip Extract, Zingiber Officinale (Ginger) Root Extract, Benzalkonium Chloride, Leuconostoc/Radish Root Ferment Filtrate, Alcohol, Methylparaben, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Butylparaben, Ethylparaben, Propylparaben, Isobutylparaben

Questions or Comments?

1-800-321-4576 M-F 8 a.m.-5 p.m.

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

AMBI ® SKINCARE

EVEN & CLEAR®
Acne Spot
Treatment

Advanced 5%
Micro-Benzoyl Peroxide

Fast & Gentle
Advanced Formula

NET WT. 1 OZ. (28 g)

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Ambi Acne Spot Treatment

Benzoyl Peroxide CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0187-5485
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE BENZOYL PEROXIDE 1.4 g

Inactive Ingredients

Ingredient Name Strength
water
GLYCERIN
methylpropanediol
PHENOXYETHANOL
SODIUM HYDROXIDE
SODIUM BENZOATE
LEVOMENOL
ETHYLHEXYLGLYCERIN
EDETATE SODIUM
BUTYLENE GLYCOL
CHAMOMILE
PSEUDOPTEROGORGIA ELISABETHAE
GINGER
benzalkonium chloride
ALCOHOL
METHYLPARABEN
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER
BUTYLPARABEN
ETHYLPARABEN
PROPYLPARABEN
isobutylparaben

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 28 in 1 TUBE
2 NDC:0187-5485-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2014-01-17


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