ADAPALENE by RUGBY LABORATORIES, INC. / Sun Pharma Canada Inc. ADAPALENE gel

ADAPALENE by

Drug Labeling and Warnings

ADAPALENE by is a Otc medication manufactured, distributed, or labeled by RUGBY LABORATORIES, INC., Sun Pharma Canada Inc. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Adapalene USP, 0.1% (retinoid) 1

1 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.

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

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 oncedaily
• 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?

1-866-923-4914

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Distributed by:
RUGBY ®LABORATORIES
Indianapolis, IN 46268

PRINCIPAL DISPLAY PANEL - 45 g Tube carton

Rugby ®

NDC: 0536-1412-26

Compare to the
active ingredient
in Differin ®Gel †

Adapalene
Gel USP, 0.1%
Acne Treatment

Previously available only
by prescription
FDA approved
Dermatologist developed
Once Daily Topical Retinoid*

*Read consumer information
leaflet before use

NET WT 1.6 OZ (45 g)

INGREDIENTS AND APPEARANCE

ADAPALENE 
adapalene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1412
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)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
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: 0536-1412-20	1 in 1 CARTON	02/20/2024
1		15 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0536-1412-26	1 in 1 CARTON	02/20/2024
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	ANDA215940	02/20/2024

Labeler - RUGBY LABORATORIES, INC. (079246066)

Establishment
Name	Address	ID/FEI	Business Operations
Sun Pharma Canada Inc.		243339023	manufacture(0536-1412)