Zzip Cold Sore Treatment
FDA Label NDC 70019-100

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zzip Ag for the product Zzip Cold Sore Treatment (NDC 70019-100). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Drug Facts

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Distributed In The Usa By:

→ Product Labeling

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.