COLD SORE TREATMENT- allantoin, lidocaine gel

Cold Sore TREATMENT by

Drug Labeling and Warnings

Cold Sore TREATMENT by is a Otc medication manufactured, distributed, or labeled by Dimensional Merchandising Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

​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 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​

KEEP OUT OF REACH OF CHILDREN

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.

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

INGREDIENTS AND APPEARANCE

COLD SORE TREATMENT 
allantoin, lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61383-018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.5 g  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SARRACENIA PURPUREA (UNII: FOP08H143P)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
MELISSA OFFICINALIS (UNII: YF70189L0N)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CERAMIDE AP (UNII: F1X8L2B00J)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE NP (UNII: 4370DF050B)
CHOLESTEROL (UNII: 97C5T2UQ7J)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61383-018-01	1 in 1 BLISTER PACK	12/01/2017
1	NDC: 61383-018-11	3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/01/2017

Labeler - Dimensional Merchandising Inc. (076693183)