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Cold Sore TREATMENT by Dimensional Merchandising Inc.

Medically reviewed on January 24, 2018

Dosage form: gel
Ingredients: ALLANTOIN 0.5g in 100g, LIDOCAINE 0.5g in 100g
Labeler: Dimensional Merchandising Inc.
NDC Code: 61383-018

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Cold Sore TREATMENT GEL

​Drug Facts

​Active Ingredients

Allantoin 0.50% (W/W)

Lidocaine 0.50% (W/W)

​Purpose

skin 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

​Warnings

​For external use only

When using this produc

• 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​

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

​Directions

• 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

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

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

​Questions or comments?

​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.

​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

COLD SORE TREATMENT 
allantoin, lidocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61383-018
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (ALLANTOIN) ALLANTOIN0.5 g  in 100 g
LIDOCAINE (LIDOCAINE) LIDOCAINE0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
SARRACENIA PURPUREA 
ALOE VERA LEAF 
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER 
MELISSA OFFICINALIS 
GLYCYRRHIZINATE DIPOTASSIUM 
PHYTOSPHINGOSINE 
CARBOXYPOLYMETHYLENE 
CERAMIDE AP 
CERAMIDE 1 
CERAMIDE NP 
CHOLESTEROL 
XANTHAN GUM 
SODIUM HYDROXIDE 
SODIUM LAUROYL LACTYLATE 
HEXYLENE GLYCOL 
ETHYLHEXYLGLYCERIN 
CAPRYLYL GLYCOL 
PHENOXYETHANOL 
Packaging
#Item CodePackage Description
1NDC:61383-018-011 TUBE in 1 BLISTER PACK
1NDC:61383-018-113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/01/2017
Labeler - Dimensional Merchandising Inc. (076693183)

 
Dimensional Merchandising Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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