Proactiv MD ® Adapalene Gel 0.1% Acne Treatment

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Adapalene 0.1% (retinoid)¹

1 read consumer information leaflet

Purpose

OTC - PURPOSE SECTION

Acne treatment

Use

INDICATIONS & USAGE SECTION

• For the treatment of acne

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

• on damaged skin (cuts, abrasions, eczema, sunburn)
• if you are allergic to adapalene or any of the ingredients in this product.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

When using this product

OTC - WHEN USING SECTION

• limit sun exposure, including light from tanning beds, and use sunscreen when going outdoors
• do not wax to remove hair in areas where the product has been applied
• during the early weeks of use, your acne may appear to worsen before it improves (this is normal); continue using as directed, unless you get irritation that becomes severe
• irritation (redness, itching, dryness, burning) is more likely to occur:
  • in the first few weeks of use
  • if using more than one topical acne medication at a time
  • but irritation usually lessens with continued use of this product
• it may take up to 3 months of once daily use to see results
• avoid product contact with eyes, lips, and mouth. If contact occurs, immediately flush the area with water.
• wash hands after use

Stop use and ask a doctor if

OTC - STOP USE SECTION

• you become pregnant, or are planning to become pregnant, while using the product
• you have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids, and shortness of breath)
• irritation becomes severe
• you see no improvement after 3 months of once daily use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older:

• use once daily
• clean the skin gently and pat dry before applying the product
• cover the entire affected area with a thin layer. For example, if your acne is on the face, apply the product to the entire face.
• do not use more than one time a day. Applying more than directed will not provide faster or better results, but may worsen skin irritation.

Children under 12 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

• store at room temperature 68°- 77°F
• protect from freezing

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer 940, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water and sodium hydroxide. May contain hydrochloric acid to adjust pH.

Questions?

OTC - QUESTIONS SECTION

1-866-735-4137

SPL UNCLASSIFIED SECTION

Distributed by The Proactiv Company LLC
100 N Sepulveda Blvd., El Segundo, CA 90245

PRINCIPAL DISPLAY PANEL - 15 g Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

proactiv MD_®

ADAPALENE GEL 0.1%
ACNE TREATMENT

First FDA-Approved
Over-the-Counter
Topical Retinoid* for
Acne Treatment

Previously Available
Only By Prescription

Dermatologist
Developed and Tested

*Read carton and enclosed consumer
information leaflet before using
this product. Keep this carton and
consumer information leaflet.
They contain important information.

NET WT 0.5 OZ (15 g)

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

• Proactiv MD Adapalene Acne Treatment
• Adapalene
• CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
• EDETATE DISODIUM
• METHYLPARABEN
• POLOXAMER 182
• PROPYLENE GLYCOL
• WATER
• SODIUM HYDROXIDE

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

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Orange Book products#

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Observed Orange Book product history#

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Product history page 1 of 2 · 43 observed states.

Observed Orange Book exclusivity history#

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Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.