COLD SORE TREATMENT- allantoin, lidocaine hydrochloride 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 0.5% 

Lidocaine HCl 0.5%

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

Warnings

For external use only

Allergy alert: Do not use if you have an allergy to Lidocaine or other "caine" ingredients.

Do not use on

deep or puncture wounds  animal bites

serious burns

When using this product avoid contact with the eyes.

Stop use and ask a doctor if

condition worsens

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

If pregnant or breast-feeding, ask a health professional before use.

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

adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily

children under 2 years of age: consult a doctor

Inactive ingredients

Water (Aqua), Glycerin, Aloe Barbadensis Leaf Juice, Alcohol, Carbomer, Sarracenia Leucophylla Flower/Leaf/Seed/Stalk Extract, Phenoxyethanol, Sodium Hydroxide, Caprylyl Glycol, Lavandula Angustifolia (Lavender) Flower Extract, Melissa Officinalis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Ethylhexylglycerin, Hexylene Glycol, Dipotassium Glycyrrhizate, Hypericum Perforatum Flower/Leaf Extract, Camellia Sinensis Leaf Extract, Acanthopanax Senticosus (Eleuthero) Root Extract

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?

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

Monday-Friday 9am-5pm ET

SPL UNCLASSIFIED SECTION

relieves dryness soothes

EXTERNAL ANALGESIC/LIP PROTECTANT

Fast and effective temporary relief of pain and itching

Moisturizing formula with Aloe

Aubio TM  Cold Sore Treatment Gel provides fast and effective temporary relief of cold sore pain and itching.

Patent Pending

Distributed by Aubio Life Sciences, LLC

Wixom, MI 48393

Aubio Life SciencesTM

www.aubio.com

Packaging

INGREDIENTS AND APPEARANCE

COLD SORE TREATMENT 
allantoin, lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61383-148
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 HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALCOHOL (UNII: 3K9958V90M)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
SARRACENIA PURPUREA (UNII: FOP08H143P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
LICORICE (UNII: 61ZBX54883)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
ST. JOHN'S WORT (UNII: UFH8805FKA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ELEUTHERO (UNII: ZQH6VH092Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61383-148-01	1 in 1 BLISTER PACK	04/09/2018
1	NDC: 61383-148-11	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	04/09/2018

Labeler - Dimensional Merchandising Inc. (076693183)