DOCOSANOL by Aleor Dermaceuticals Limited Docosanol Cream, 10%

DOCOSANOL by

Drug Labeling and Warnings

DOCOSANOL by is a Otc medication manufactured, distributed, or labeled by Aleor Dermaceuticals Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOCOSANOL- docosanol cream 
Aleor Dermaceuticals Limited

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Docosanol Cream, 10%

Active ingredient

Docosanol 10%

Purpose

Cold sore/fever blister treatment

Uses

  • treats cold sores/fever blisters on the face or lips
  • shortens healing time and duration of symptoms:
  • tingling, pain, burning, and/or itching

WARNINGS

Allergy Alert

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

  • hives
  • facial swelling
  • wheezing/difficulty breathing
  • shock
  • rash

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

For external use only

Do not use

  • if you are allergic to any ingredient in this product

When using this product

  • apply only to the affected areas
  • do not use in or near the eyes
  • avoid applying directly inside your mouth
  • do not share this product with anyone. This may spread the infection.

Stop use and ask a doctor if

  • your cold sore gets worse or the cold sore is not healed within 10 days

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 or over:
  • wash hands before and after applying cream
  • apply to affected area on the face or lips at the first sign of cold sore/fever blister (tingle).
  • early treatment ensures the best results
  • rub in gently but completely
  • use 5 times a day until healed
  • children under 12 years: ask a doctor

Other information

  • store at 20° to 25°C (68° to 77°F)
  • do not freeze

Inactive ingredient

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

Questions or comments?

Call 1-866-210-9797 Monday-Friday 9AM-6PM EST

PRINCIPAL DISPLAY PANEL

Tube pack

NDC: 71589-019-01

Docosanol Cream, 10%

Compare to the active ingredient in Abreva®**

Cold Sore/Fever Blister Treatment

Non-prescription Medicine to Shorten Healing Time*

Cold Sore Treatment

For Topical Use Only

NET WT 2g (0.07 oz)

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

*Contains the only non-prescription cold sore medicine approved by the FDA to shorten healing time and duration of symptoms.

RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS

Manufactured for:

Aleor Dermaceuticals Ltd.,

Karakhadi, Vadodara 391450, India.

tube pack

PUMP PACK

NDC: 71589-019-03

Docosanol Cream, 10%

Compare to the active ingredient in Abreva®**

Cold Sore/Fever Blister Treatment

Non-prescription Medicine to Shorten Healing Time*

Cold Sore Treatment

For Topical Use Only

NET WT 2g (0.07 oz)

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

*Contains the only non-prescription cold sore medicine approved by the FDA to shorten healing time and duration of symptoms.

RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS

Manufactured for:

Aleor Dermaceuticals Ltd.,

Karakhadi, Vadodara 391450, India.

 

pump pack
DOCOSANOL 
docosanol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71589-019
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: 71589-019-011 in 1 PACKAGE05/03/202203/12/2025
12 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 71589-019-031 in 1 PACKAGE05/03/202203/12/2025
22 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21583905/03/202203/12/2025
Labeler - Aleor Dermaceuticals Limited (871411532)
Registrant - Aleor Dermaceuticals Limited (871411532)
Establishment
NameAddressID/FEIBusiness Operations
Aleor Dermaceuticals Limited871411532MANUFACTURE(71589-019) , ANALYSIS(71589-019)

Revised: 3/2025