Label: ZZIP COLD SORE TREATMENT- allantoin, dimethicone, menthol solution
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Contains inactivated NDC Code(s)
NDC Code(s): 70019-100-00 - Packager: Zzip AG
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 30, 2015
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- Drug Facts
- Uses
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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
- Inactive Ingredients
- Questions or comments?
- Distributed in the USA by:
- Product labeling
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INGREDIENTS AND APPEARANCE
ZZIP COLD SORE TREATMENT
allantoin, dimethicone, menthol solutionProduct 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)
