OTC Labels

Over the Counter Medications

OTC Medication Information: M.D. FORTE Glycare Perfection

By Allergan, Inc. | Last revised: 30 November 2010

M.D. FORTE GLYCARE PERFECTION- salicylic acid gel
Allergan, Inc.

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 Facts

Active Ingredient

Salicylic Acid 1%

Purpose

Acne Treatment

Uses

  • clears up acne blemishes
  • helps prevent new acne blemishes

Warnings

For external use only

Do not use

  • with other acne medications or if you are sensitive to salicylic acid.

When using this product

  • avoid unnecessay sun exposure and use sunscreen.
  • keep away from eyes, lips and mouth.
  • this product may cause irritation, characterized by redness, burning, itching, peeling or possible swelling.

More frequent use or higher concentrations may aggravate such irritation.

Stop use and ask a doctor if

  • condition worsens or does not improve after regular use.

Keep out of the reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • cleanse skin thoroughly before applying medication.
  • cover the entire affected area with a thin layer 1 to 3 times daily.
  • because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a physician.
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Other information

store at 20-25°C (68-77°F)

Inactive ingredients

water (agua), sd alcohol 40-b, glycolic acid (and) ammonium glycolate, hydroxypropyl methylcellulose

NDC 0023-9217-17

GLYCARE

PERFECTION

GEL

ACNE

MEDICATION

M.D. FORTÉ®

1.7 FL. OZ. (50ml)

Carton
(click image for full-size original)
M.D. FORTE GLYCARE PERFECTION
salicylic acid gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0023-9217
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
salicylic acid (salicylic acid) salicylic acid 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water
alcohol
glycolic acid
ammonia
hypromellose 2208 (100 MPA.S)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0023-9217-17 1 TUBE (1 TUBE) in 1 CARTON contains a TUBE
1 50 mL in 1 TUBE This package is contained within the CARTON (0023-9217-17)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 02/04/1997 12/02/2012
Labeler — Allergan, Inc. (144796497)
Establishment
Name Address ID/FEI Operations
Ei, Inc. 105803274 MANUFACTURE (0023-9217)

Revised: 11/2010 Allergan, Inc.

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