Docosanol Cream, 10%

Docosanol Cream, 10%
SPL v4
SPL
SPL Set ID 3eb9cf4a-4be8-4648-b63c-2eb7377588cf
Route
TOPICAL
Published
Effective Date 2023-06-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docosanol (100 mg)
Inactive Ingredients
Benzyl Alcohol Light Mineral Oil Propylene Glycol Water Sucrose Distearate Sucrose Stearate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
ANDA Active Since 2021-12-31

Description

 Docosanol  10%

Purpose

Cold sore/fever blister treatment


Medication Information

Purpose

Cold sore/fever blister treatment

Description

 Docosanol  10%

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
  • shock
  • rash

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

For external use only

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
Do Not Use
  •  if you are allergic to any ingredient in this product
Package Label
MEIJER Cold Sore Fever Blister Treatment
Active Ingredient

 Docosanol  10%

Other Information
  • store at 20° to 25°C (68° to 77°F)
  • do not freeze
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 ABREVA® ACTIVE INGREDIENT**

Docosanol Cream 10%

COLD SORE/FEVER BLISTER TREATMENT

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, owner of the registered trademark Abreva®.

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

RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS 

DIST. BY MEIJER DISTRIBUTION, INC.

GRAND RAPID, MI 49544

www.meijer.com

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.


Structured Label Content

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

Cold sore/fever blister treatment

Warnings

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

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

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

For external use only

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
Do Not Use (Do not use)
  •  if you are allergic to any ingredient in this product
Package Label
MEIJER Cold Sore Fever Blister Treatment
Active Ingredient (Active ingredient)

 Docosanol  10%

Other Information (Other information)
  • store at 20° to 25°C (68° to 77°F)
  • do not freeze
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel

COMPARE TO ABREVA® ACTIVE INGREDIENT**

Docosanol Cream 10%

COLD SORE/FEVER BLISTER TREATMENT

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, owner of the registered trademark Abreva®.

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

RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS 

DIST. BY MEIJER DISTRIBUTION, INC.

GRAND RAPID, MI 49544

www.meijer.com

When Using 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 (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. (Keep out of reach of children.)

 If swallowed, get medical help or contact a Poison Control Center right away.


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