SPL v2
SPL
SPL Set ID 3a7ddfe4-8b2e-898e-e063-6394a90ac640
Route
TOPICAL
Published
Effective Date 2025-06-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docosanol (10 g)
Inactive Ingredients
Tartaric Acid Sucrose Stearate Propylene Glycol 2-stearate Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-06-02

Description

Docosanol 10%-------------Cold sore / fever blister treatment

Dosage and Administration

Wash hands before and after applying, adults and children12 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 12 years of age: Consult a doctor.


Medication Information

Dosage and Administration

Wash hands before and after applying, adults and children12 years of age

and older: Apply to affected area not more than 3 to 4 times daily. Children under 12 years

of age: Consult a doctor.

Description

Docosanol 10%-------------Cold sore / fever blister treatment

Uses

For the temporary relief of pain and itching associated with cold sores and fever blisters. Relieves dryness and softens cold sores and fever blisters.

Lable

Stop Use

if your cold sore gets worse or the cold soreis not healed within 10 days.

Warnings

Allergy Test-Apply a small amount of this cold sore product behind the ear or on the inner wrist.Check for allergic reactionssuch as itching,redness,orrash within 48hours.If any occur, discontinue use and seek medical help immediately.For external use only do

not useif you are allergic to anyingredient in this product.

Directions:

Wash hands before and after applying, adults and children12 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 12 years of age: Consult a doctor.

Ask A Doctor

if your cold sore gets worse or the cold soreis not healed within 10 days.

Other Information

Store a troom temperature and avoid excessive heat

Active Ingredients

Docosanol 10%-------------Cold sore / fever blister treatment

Inactive Ingredients

Light mineral oil, Sucrose stearate, Propylene glycol, Purified water.

When Using This Product

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

Keep Out of Reach of Children

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


Structured Label Content

Uses

For the temporary relief of pain and itching associated with cold sores and fever blisters. Relieves dryness and softens cold sores and fever blisters.

Lable

Stop Use (Stop use)

if your cold sore gets worse or the cold soreis not healed within 10 days.

Warnings

Allergy Test-Apply a small amount of this cold sore product behind the ear or on the inner wrist.Check for allergic reactionssuch as itching,redness,orrash within 48hours.If any occur, discontinue use and seek medical help immediately.For external use only do

not useif you are allergic to anyingredient in this product.

Directions:

Wash hands before and after applying, adults and children12 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 12 years of age: Consult a doctor.

Ask A Doctor (Ask a doctor)

if your cold sore gets worse or the cold soreis not healed within 10 days.

Other Information (Other information)

Store a troom temperature and avoid excessive heat

Active Ingredients (Active ingredients)

Docosanol 10%-------------Cold sore / fever blister treatment

Inactive Ingredients

Light mineral oil, Sucrose stearate, Propylene glycol, Purified water.

When Using This Product (When using this product)

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

Dosage and Administration (Dosage and administration)

Wash hands before and after applying, adults and children12 years of age

and older: Apply to affected area not more than 3 to 4 times daily. Children under 12 years

of age: Consult a doctor.

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.


Advanced Ingredient Data


Raw Label Data

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