ZZIP COLD SORE TREATMENT- allantoin, dimethicone, menthol solution 
Zzip AG

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.

----------

Zzip Cold Sore Treatment

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

label1

label2

label3

ZZIP COLD SORE TREATMENT 
allantoin, dimethicone, menthol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70019-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN5 mg  in 1 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE10 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70019-100-003 mL in 1 TUBE; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/30/2015
Labeler - Zzip AG (480040768)
Registrant - H en L Verpakkingen B.V. (407736821)
Establishment
NameAddressID/FEIBusiness Operations
H en L Verpakkingen B.V.407736821manufacture(70019-100)
Establishment
NameAddressID/FEIBusiness Operations
Flores Natural Cosmetic404875689pack(70019-100)

Revised: 7/2015
Document Id: 9adde184-b4c5-4dfd-b2e0-a30ee8caff08
Set id: cf62370a-9a10-46b1-b320-23eaf196040c
Version: 1
Effective Time: 20150730
 
Zzip AG