FDA.reportPublic FDA data

Aubio Life Sciences Lip

Manufacturer
Aubio Life Sciences LLC | KLEEN CONCEPTS
Effective date
2016-01-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:11

Label at a glance#

ProductAubio Life Sciences Lip
Active ingredientAllantoin, Lidocaine
Label structure10 sections

Indications and 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

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Allantoin 0.50% (W/W)

Lidocaine 0.50% (W/W)

Purpose

OTC - PURPOSE SECTION

skin protectant

external analgesic

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes

Stop use and ask a doctor

OTC - STOP USE SECTION

  • 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 SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

OTHER SAFETY 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1739846allantoin 0.5 % / lidocaine 0.5 % Topical CreamPSN1
1739846allantoin 5 MG/ML / lidocaine 5 MG/ML Topical CreamSCD1
1739846allantoin 0.5 % / lidocaine 0.5 % Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70365-001-012020-01-31C16284748780-19d75b9d0-5e9f-f424-e053-dadaa90a57ce698dbeac-8aca-4d8a-aa8b-0e0b02227805

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70365-001-01Aubio Life Sciences Lip3 g in 1 BLISTER PACKCREAM31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70365-001AUBIO LIFE SCIENCES LIP (ALLANTOIN AND LIDOCAINE) CREAM [AUBIO LIFE SCIENCES LLC]1Legacy NDC, 1 package rows20160228_698dbeac-8aca-4d8a-aa8b-0e0b02227805.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70365-00170365-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
Allantoin344S277G0ZACTIB
Lidocaine98PI200987ACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
Aloe vera LeafZY81Z83H0XIACT
Carbomer Interpolymer Type A (allyl sucrose crosslinked)59TL3WG5COIACT
PhenoxyethanolHIE492ZZ3TIACT
Caprylic AlcoholNV1779205DIACT
Ethylhexylglycerin147D247K3PIACT
Hexylene GlycolKEH0A3F75JIACT
Glycyrrhizinate DipotassiumCA2Y0FE3FXIACT
PhytosphingosineGIN46U9Q2QIACT
Sodium Lauroyl Lactylate7243K85WFOIACT
Xanthan GumTTV12P4NEEIACT
Cholesterol97C5T2UQ7JIACT
Ceramide NP4370DF050BIACT
3-Dehydroxy Ceramide 1CR0J8RN66KIACT
Ceramide APF1X8L2B00JIACT
Lavandula Angustifolia Flower19AH1RAF4MIACT
Melissa OfficinalisYF70189L0NIACT
Sarracenia PurpureaFOP08H143PIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
eba3afd5-f152-45c8-a5a2-dc28593abd7e698dbeac-8aca-4d8a-aa8b-0e0b022278052016-01-31WarningsExact identifier
spl id: eba3afd5-f152-45c8-a5a2-dc28593abd7e
spl set id: 698dbeac-8aca-4d8a-aa8b-0e0b02227805

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.