COLD SORE FEVER BLISTER TREATMENT- docosanol cream 
P & L Development, LLC

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Docosanol Cream, 10%

Active ingredient

 Docosanol  10%

Purpose

Cold sore/fever blister treatment

Uses

Warnings

Allergy Alert: This product may cause a severe allergic reaction. Symptoms may include:

If an allergic reaction occurs, stop use and seek medical help right away.

For external use only

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

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

Directions

Other information

Inactive ingredients

benzyl alcohol, light mineral oil, propylene glycol, purified water, sucrose distearate, sucrose stearate

Questions or comments?

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

Principal Display Panel

†ompare to the active ingredient in Abreva®

Docosanol Cream, 10%

Cold sore/fever blister treatment

Portable convenient pump

NET WT 2 g (0.07 oz)

*Docosanol Cream, 10% contains the only OTC medicine approved by the FDA to shorten healing time and duration of symptoms.

†This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, distributor of Abreva®.

RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

Package Label

Docosanol 10%

PL DEVELOPMENTS Cold Sore Fever Blister Treatment

COLD SORE FEVER BLISTER TREATMENT 
docosanol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-877
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCOSANOL (UNII: 9G1OE216XY) (DOCOSANOL - UNII:9G1OE216XY) DOCOSANOL100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SUCROSE DISTEARATE (UNII: 33X4X4B90S)  
SUCROSE STEARATE (UNII: 274KW0O50M)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59726-877-072 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20875412/31/2023
Labeler - P & L Development, LLC (800014821)

Revised: 3/2023
Document Id: 09a73a90-80b6-43e8-aa58-c35b4d58fb67
Set id: e88e49b9-c292-48c5-b19e-630ffa6447e7
Version: 2
Effective Time: 20230322
 
P & L Development, LLC