ZZIP COLD SORE TREATMENT- allantoin, dimethicone, menthol solution

Zzip Cold Sore Treatment by

Drug Labeling and Warnings

Zzip Cold Sore Treatment by is a Otc medication manufactured, distributed, or labeled by Zzip AG, H en L Verpakkingen B.V., Flores Natural Cosmetic. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

​Active Ingredients

​Allantoin 0.5%

Dimethicone 1%

Menthol 0.1%

Purpose

Cold sore/fever blister treatment

Uses

- Temporarily relieves the pain and itching associated with cold sores/fever blisters.

- Temporarily protects and helps relieve chapped or cracked lips.

Warnings

For external use only

Do not use

- if you are allergic to any ingredient in this product

- during pregnancy or breast-feeding.

When using this product

- avoid contact with eyes

- apply only to affected areas

- avoid applying directy inside your mouth

- do not share this product with anyone. This may spread infection.

- dispose cotton swab immediately after use

- discard after 1 month of opening the tube

Stop use and ask a doctor if

- condition worsens

- symptoms last more than 7 days

- symptoms clear up and return in a few days.

Keep out of reach of children.

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

Directions

​adults and children 12 years or over:​

- Apply to affected area on face or lips at first sign (tingle) of cold sore/fever blister

- Open tube, saturate cotton swab with 8 drops of liquid

- Use the cotton swab to apply to affeted area on face or lips. Do ot touch the sore with your fingers. Continue for 3 seconds until the cold sore is completely covered and sealed.

- Dispose of cotton swab - do not reuse

- Wash hands before and after application.

- Apply 2 times daily, not to exceed 3 to 4 times daily until sore is healed

​children under 12 years: ask a doctor

Other information

Store at room temperature

Do not freeze

Inactive Ingredients

Aloe Barbadensis, Calendula Officinalis Flower, Copper Sulfate, Demineralized water, Ethylhexylglycerin, Glycerin, Laureth-9, Maltodextrin, Opuntia Ficus Indica Stem, PEG-40 Hydrogenated CAstor Oil, Pentylene Glycol, Phenoxyethanol, Propylene Glycol, Rhododendrum Ferrugineum, Trideceth-9.

Questions or comments?

Call 1-800-257-7071 (English/Spanish) Weekdays

Visit us at www.zzipusa.com

Distributed in the USA by:

GG Advisors, LLC

923 Haddonfield Rd., Suite 300

Cherry Hill, NJ 08002

1-800-257-7071

Switzerland developed by Zzip AG

Made in the Netherlands

Product labeling

INGREDIENTS AND APPEARANCE

ZZIP COLD SORE TREATMENT 
allantoin, dimethicone, menthol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70019-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	5 mg  in 1 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	10 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
BASIC COPPER SULFATE (UNII: CUP529P5NS)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
LAURETH-9 (UNII: 0AWH8BFG9A)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
TRIDECETH-9 (UNII: X9HD79I514)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70019-100-00	3 mL in 1 TUBE; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/30/2015

Labeler - Zzip AG (480040768)

Registrant - H en L Verpakkingen B.V. (407736821)

Establishment
Name	Address	ID/FEI	Business Operations
H en L Verpakkingen B.V.		407736821	manufacture(70019-100)

Establishment
Name	Address	ID/FEI	Business Operations
Flores Natural Cosmetic		404875689	pack(70019-100)