FDA Label for Panoxyl

Other

Drug Facts

Distributed by:
Crown Laboratories, Inc.
Johnson City, TN 37604

P12165.02 panoxyl.com

Made in Canada

Active Ingredient

Adapalene USP, 0.1% (retinoid)

read consumer information leaflet

Purpose

Acne treatment

Use

• For the treatment of acne

Warnings

For external use only

Do Not Use

• 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

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

When Using This Product

• 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 Doctor If

• 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

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

Directions

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

• TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.
• store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
• protect from freezing

Inactive Ingredients

carbomer homopolymer type C, edetate disodium, phenoxyethanol, poloxamer 182, propylene glycol, purified water, sodium hydroxide.

Questions?

1-833-279-6522

Principal Display Panel - 15 G Carton