Cold Sore TREATMENT GEL

Manufacturer
Dimensional Merchandising Inc.
Effective date
2018-01-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:04:01

Label at a glance#

ProductCold Sore TREATMENT
Active ingredientALLANTOIN, LIDOCAINE
Label structure11 sections

Indications and 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

Dosage and administration

• Wash hands before and after applying gel • Gently clean the affected area before applying • Always rub gently into affected area • Adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily • Children under 2 years of age, consult a doctor

Storage and handling

• Recap after each use • Store at room temperature • Protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

​Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Allantoin 0.50% (W/W)

Lidocaine 0.50% (W/W)

​Purpose

OTC - PURPOSE SECTION

skin protectant

external analgesic          

​Uses

INDICATIONS & USAGE SECTION

• For the temporary relief of pain and itching associated with cold sores and fever blisters

• Relieves dryness and softens cold sores and fever blisters

​Warnings

WARNINGS SECTION

​For external use only

When using this product 

• avoid contact with the eyes

Stop use and ask a doctor

• if condition worsens

• if symptoms persist for more than 7 days or clear up and occur again within a few days​

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away

​Directions

DOSAGE & ADMINISTRATION SECTION

• Wash hands before and after applying gel

• Gently clean the affected area before applying

• Always rub gently into affected area

• Adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily

• Children under 2 years of age, consult a doctor

​Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycerin, Sarracenia Stalk/Flower/Seed Extract (and) Sarracenia Purpurea Leaf/Stalk/Flower/Seed Extract, Aloe Barbadensis Leaf Juice, Lavandula Angustifolia (Lavender) Flower Extract, Melissa Officinalis (Balm Mint) Extract, Dipotassium Glycyrrhizate, Phytosphingosine, Carbomer, Ceramide AP, Ceramide EOP, Ceramide NP, Cholesterol, Xanthan Gum, Sodium Hydroxide, Sodium Lauroyl Lactylate, Hexylene Glycol, Ethylhexylglycerin, Caprylyl Glycol, Phenoxyethanol

​Other Information

STORAGE AND HANDLING SECTION

• Recap after each use • Store at room temperature • Protect the product in this container from excessive heat and direct sun

​Questions or comments?

OTC - QUESTIONS SECTION

​We Value your feedback​​

Call Toll-free 1-844-My-Aubio (1-844-692-8246)

If you are not completely satisfied, save receipt and remaining product and call us weekdays 9am-5pm EST.

SPL UNCLASSIFIED SECTION

​External Analgesic Lip Protectant

Relief in hours

Relieves pain and itch. Cools and soothes. Ultra-effective formula with Botanicals.

Aubio's active ingredients quickly relieve cold sore pain and discomfort. Aubio's formula also contains inactive Sarracenia, a carnivorous plant extract, used by Native Americans for centuries (Natures Golden Drop). Try Aubio today for Aubi fast relief.

What make Aubio different - IT REALLY WORKS!

Nature's Golden Drop

This Product Not Tested on Animals

Manufactured by DMI, NJ.

Distributed by ​Aubio Life Sciences, LLC Delray Beach, FL 33444

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61383-01861383-018-11, 61383-018-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a9071263-fca7-44a9-a301-affcf5ed17bed1ac9fa6-3ceb-472d-a8a9-47817bef07bb2023-06-08WarningsExact identifier
spl set id: d1ac9fa6-3ceb-472d-a8a9-47817bef07bb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.