Drugplain

ABREVA 100 mg/g

docosanol · CREAM · Haleon US Holdings LLC

No Recall History
Plain English

ABREVA is a cream containing docosanol at 100 mg/g, taken topical. Manufactured by Haleon US Holdings LLC.

Key Facts

Brand Name
ABREVA
Generic Name
docosanol
NDC Code (Product)
0135-0200
Manufacturer
Haleon US Holdings LLC
Strength
100 mg/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
NDA020941
Marketing Start
03/19/2010

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective7,033 reports
oral herpes2,449 reports
condition aggravated1,957 reports
drug administration error1,779 reports
incorrect drug administration duration803 reports
herpes simplex706 reports
incorrect product administration duration637 reports
lip swelling556 reports
wrong technique in product usage process551 reports
product quality issue539 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 Softens crust (scabs) associated with cold sores and fever blisters

Dosage & Administration

Directions push and turn cap to open, close tightly after use wash hands before and after applying adults and children 12 years of age and older : apply to affected area not more than 3 to 4 times daily children under 12 years : consult a doctor

Warnings

Warnings For external use only Do not use in large quantities, particularly over raw surfaces, or blistered areas When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is ABREVA used for?

ABREVA contains docosanol. It is a cream taken topical. Consult your doctor for specific uses.

Is ABREVA a controlled substance?

ABREVA is not classified as a controlled substance by the DEA.

What is the generic name for ABREVA?

The generic name for ABREVA is docosanol. There are 11 other brand versions of docosanol.

What is the NDC code for ABREVA 100 mg/g?

The NDC (National Drug Code) for ABREVA 100 mg/g is 0135-0200, listed by Haleon US Holdings LLC.

Product NDC

0135-0200

Package NDC

0135-0200-01

Other ABREVA Dosages

Other Docosanol Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)