HERPETINO COLD SORE RELIEF TERRY NATURALLY BRAND- allantoin cream
EuroPharma, Inc

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.

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Herpetino Cold Sore Relief Terry Naturally Brand

Drug Facts

Active Ingredient

Allantoin 1%

Purpose

Cold sore/fever blister treatment and skin protectant

Uses

• Relieves dryness and softens cold sores and fever blisters.
• Softens scabs associated with cold sores and fever blisters.
• Helps prevent, protect, and soothe chapped, cracked skin and lips.

Warnings

For external use only.

When using this product

• Avoid contact with eyes.

Do not use on:

• deep or puncture wounds • animal bites • serious burns

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 the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Apply at first sign of cold sore or fever blister, several times daily.

Inactive ingredients:

Bisabolol (Chamomile), Dimethicone, Hexyl Laurate, Jojoba (Simmondsia Chinensis) Seed Oil, Panthenol, Polyglyceryl-4 Isostearate, Polyisobutane, Propolis Extract, Shea (Butyrospermum Parkii) Butter, Sodium Chloride, Sweet Almond (Amygdalus Dulcis) Oil, Tocopheryl Acetate, Water, Xylitol.

Package Labeling:

Label Tube

HERPETINO COLD SORE RELIEF TERRY NATURALLY BRAND
allantoin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67703-000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
CHAMOMILE (UNII: FGL3685T2X)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
JOJOBA OIL (UNII: 724GKU717M)
PANTHENOL (UNII: WV9CM0O67Z)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
SHEA BUTTER (UNII: K49155WL9Y)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALMOND OIL (UNII: 66YXD4DKO9)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67703-000-00	1 in 1 BOX	03/15/2018	10/31/2020
1		10 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	03/15/2018	10/31/2020

Labeler - EuroPharma, Inc (060446577)

Registrant - EuroPharma, Inc (060446577)

Revised: 6/2019

Document Id: 8aa8ee11-19ee-82a1-e053-2995a90ad7b0

Set id: c298d8ac-c117-4b02-a220-f22f465c3085

Version: 3

Effective Time: 20190606

EuroPharma, Inc