Docosanol - DailyMed Details

Docosanol

SPL v1

SPL

SPL Set ID f0b3a78b-b14c-4869-ba3b-d04ffa62e1d5

Route

TOPICAL

Published

Effective Date 2025-04-14

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 2025-04-10

Description

Drug Facts

Purpose

Cold sore/fever blister treatment

Medication Information

Purpose

Cold sore/fever blister treatment

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

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

Do Not Use

if you are allergic to any ingredient in this product

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

Active Ingredient

Docosanol 10%

Other Information

store at 20°-25°C (68°-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

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

Principal Display Panel 2 G Tube Label

NDC 61269-881-35

^†Compare to the active

ingredient in Abreva^®

Docosanol

Cream, 10%

Cold sore/fever blister treatment

Only FDA approved medicine

to shorten healing time*

Cold sore treatment

Net wt. 2 g

(0.07 oz)

H² pharma

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Purpose

Cold sore/fever blister treatment

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

Allergy Alert (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

Active Ingredient (Active ingredient)

Docosanol 10%

Other Information (Other information)

store at 20°-25°C (68°-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

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

Principal Display Panel 2 G Tube Label (PRINCIPAL DISPLAY PANEL - 2 g Tube Label)

NDC 61269-881-35

^†Compare to the active

ingredient in Abreva^®

Docosanol

Cream, 10%

Cold sore/fever blister treatment

Only FDA approved medicine

to shorten healing time*

Cold sore treatment

Net wt. 2 g

(0.07 oz)

H² pharma

Advanced Ingredient Data

[{"name": "DOCOSANOL", "unii": "9G1OE216XY", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIGHT MINERAL OIL", "unii": "N6K5787QVP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE DISTEARATE", "unii": "33X4X4B90S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE STEARATE", "unii": "274KW0O50M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "treats cold sores/fever blisters on the face or lips shortens healing time and duration of symptoms: tingling, pain, burning, and/or itching", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Purpose": "Cold sore/fever blister treatment", "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", "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", "Active ingredient": "Docosanol 10%", "Other information": "store at 20°-25°C (68°-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", "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", "PRINCIPAL DISPLAY PANEL - 2 g Tube Label": "NDC 61269-881-35 † Compare to the active ingredient in Abreva ® Docosanol Cream, 10% Cold sore/fever blister treatment Only FDA approved medicine to shorten healing time* Cold sore treatment Net wt. 2 g (0.07 oz) H 2 pharma"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:55.742168 · Updated: 2026-03-14T23:08:22.901159