Adapalene by Cardinal Health (Leader) 70000 ADAPALENE gel

Adapalene by

Drug Labeling and Warnings

Adapalene by is a Otc medication manufactured, distributed, or labeled by Cardinal Health (Leader) 70000. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Pregnancy/Breastfeeding,

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 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

• 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.

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

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

Inactive ingredients

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

Questions or comments?

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

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

LEADER Adapalene Gel

INGREDIENTS AND APPEARANCE

ADAPALENE 
adapalene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0043
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF)	ADAPALENE	1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLOXAMER 182 (UNII: JX0HIX6OAG)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0043-1	1 in 1 CARTON	02/19/2019
1		15 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 70000-0043-2	1 in 1 CARTON	02/19/2019
2		45 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091314	02/19/2019

Labeler - Cardinal Health (Leader) 70000 (097537435)