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  5. Label Information: Abreva Rapid Pain Relief

FDA Label for Abreva Rapid Pain Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS OR COMMENTS?
    13. ADDITIONAL INFORMATION
    14. PRINCIPAL DISPLAY PANEL

Abreva Rapid Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


* Please review the disclaimer below.