Aubio Life Sciences Lip
FDA Label NDC 70365-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aubio Life Sciences Llc for the product Aubio Life Sciences Lip (NDC 70365-001). 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 other, active ingredients, purpose, uses, warnings, when using this product, stop use and ask a doctor, otc - 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

Other

Drug Facts

Active Ingredients

Allantoin 0.50% (W/W)

Lidocaine 0.50% (W/W)

Purpose

skin protectant

external analgesic

Uses

  • For the temporary relief of pain and Itching associated with cold sores and fever blisters
  • Relieves dryness and softens cold sores and fever blisters

Warnings

For external use only

When Using This Product

  • avoid contact with the eyes

Stop Use And Ask A Doctor

  • if condition worsens
  • if symptoms persist for more than 7 days or clear up and occur again within a few days.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed get medical help or contact a poison control center right away

Questions Or Comments?

Call Toll-free 1-844-My-Aubío (1-844-692-8246)

Weekdays 9am-5pm PT. If you are not completely satisfied, save receipt and remaining product and call us.

Directions

  • Wash hands before and after applying gel
  • Gently clean the affected area before applying
  • Always rub gently into affected area
  • Adults and children 2 years of age and older; apply to affected area not more than 3-4 times daily
  • Children under 2 years of age, consult a doctor

Inactive Ingredients

Water (Aqua), Glycerin, Sarracenia Stalk/Flower/Seed Extract (and) Sarracenia Purpurea Leaf/Stalk/ Flower/Seed Extract, Aloe Barbadensis Leaf Juice, Lavandula Angustifolia (Lavender) Flower Extract, Melissa Officinalis (Balm Mint) Extract, Dipotassium Glycyrrhizate, Phytosphingosine, Carbomer, Ceramide AP, Ceramide EOP, Ceramide NP, Cholesterol, Xantham Gum, Sodium Hydroxide, Sodium Lauroyl Lactylate, Hexylene Glycol, Ethylhexylglycerin, Caprylyl Glycol, Phenoxytehanol

Other Information

  • Recap after each use
  • Store at room temperature
  • Protect the product in this container from excessive heat and direct sun

Principal Display Panel - Blister Pack Label

Aubío™

Cold Sore
Treatment Gel

External Analgesic Lip Protectant

Ultra-effective formula with Botanicals

Relieves pain and itch

Cools and soothes

NET WT 3g (0.11 oz)

Principal Display Panel (Blister Pack Label)

Principal Display Panel (Blister Pack Label)

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