PANOXYL- adapalene gel 
CROWN LABORATORIES

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PanOxyl ®

Drug Facts

Active ingredient

Adapalene USP, 0.1% (retinoid) 1


1
read consumer information leaflet

Purpose

Acne treatment

Use

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 right away.

Directions

Adults and children 12 years of age and older:

Children under 12 years of age:ask a doctor

Other information

Inactive ingredients

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

Questions?

1-833-279-6522

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

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

NDC 0316-0143-15

PanOxyl ®

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. 0.5 oz (15 g)

panoxyl-01

PANOXYL 
adapalene gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-0143
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF) ADAPALENE1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0316-0143-151 in 1 CARTON02/06/2023
115 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21594002/06/2023
Labeler - CROWN LABORATORIES (079035945)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295manufacture(0316-0143)

Revised: 3/2024
Document Id: 1320044a-706b-83a8-e063-6394a90a339e
Set id: 40f8d9e1-d1b9-464b-92ba-9695d419a6f7
Version: 3
Effective Time: 20240307
 
CROWN LABORATORIES