COLD SORE FEVER BLISTER TREATMENT- docosanol cream 
Rugby Laboratories, Inc.

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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

Compare to the active ingredient in Abreva®†

Docosanol Cream 10%

Cold Sore/Fever Blister Treatment 10%

Non-prescription medicine to shorten healing time*

Cold sore treatment

For Topical Use Only

NET WT 2 g (0.07 oz)

†This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Abreva®.

* Non-prescription cold sore medicine to shorten healing time and duration of symptpms.

RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS

Distributed by:

RUGBY® LABORATORIES

Indianapolis, IN 46268

www.majorpharmaceuticals.com

Package Label

Docosanol 10%

RUGBY Cold Sore Fever Blister Treatment

COLD SORE FEVER BLISTER TREATMENT 
docosanol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1379
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:0536-1379-041 in 1 PACKAGE01/01/2023
12 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20875401/01/2023
Labeler - Rugby Laboratories, Inc. (079246066)

Revised: 1/2023
Document Id: 2d766360-3ed9-4c32-8709-3f65f9ba05ee
Set id: 3204b09b-f0ee-4ca8-ac32-527bf1b383b8
Version: 1
Effective Time: 20230120
 
Rugby Laboratories, Inc.