Adapalene Gel USP 01 percent DELISTED

Label at a glance#

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-877-753-3935

Websitewww.myleader.comwww.myleader.com

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Adapalene USP 0.1% (retinoid)*

*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

Pregnancy/Breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 in 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

SPL UNCLASSIFIED SECTION

• store at rooms temperature 68º to 77ºF
• protect from freezing

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer homopolymer, edetate disodium, methylparabem, poloxamer 182, propylene glycol, purified water, sodium hydroxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO DIFFERIN® GEL active ingredient†

Adapalene Gel

USP, 0.1% | Acne Treatment

Previously available only by prescription

FDA-approved

Dermatologist Developed

Once Daily Topical Retinoid*

Oil-Free

Fragrance free

Dermatologist developed and tested

*Read consumer information leaflet before use

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON AND ENCLOSED CONSUMER INFORMATION LEAFLET FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

†This product is not manufactured or distributed by Galderma Laboratories, L.P. distributor of Differin® Gel.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Billing Units#

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

• 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

Orange Book application contexts#

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Orange Book products#

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Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 46 observed states.

Observed Orange Book normalized TE history#

openFDA label cross-check#

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Reported adverse events (FAERS/openFDA)#

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