Abreva Gel
FDA Label NDC 0135-0400

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Abreva (NDC 0135-0400). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purposes, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Glycerin 20%

Lidocaine HCl 4%

Purposes

Lip Protectant

External Analgesic

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

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.

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

Other Information

  • store at 20-25oC (68o-77oF)

Inactive Ingredients

edetate disodium, hydroxyethyl cellulose, menthol, methylparaben, polysorbate 80, propylene glycol,

propylparaben, trisodium citrate dihydrate, water

Questions Or Comments?

1-877-709-3539

Additional Information

Retain outer carton for full product uses, directions and warnings.

Do not use if carton is broken or damaged.

CARTON Recycle

Trademarks are owned by or licensed to the Haleon group of companies.

Distributed by:

Haleon

Warren, NJ 07059

Made in Canada

©2023 Haleon group of companies or its licensor.

Principal Display Panel

abreva

RAPID

PAIN RELIEF

Cold Sore

MAX

STRENGTH

LIDOCAINE

For rapid numbing effect

Lidocaine HCl 4% / Glycerin 20%

External Analgesic / Lip Protectant

NET WT 3 g (0.10 oz)

PA 202119 – Front Panel

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