FDA.reportPublic FDA data

Healthy Lips

Manufacturer
VitaMex USA, Corp
Effective date
2024-11-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:38:15

Label at a glance#

ProductHealthy Lips
Active ingredientSALICYLIC ACID
Label structure12 sections

Indications and uses

Uses: For temporary relief of pain associated with cancker sores.

Dosage and administration

Directions: Use child resistant dropper. children 14 years of age to adult. Apply 2 drops 2 times a day to affected area of the mouth, gums or mucous membranes (throat). Do not rinse mouth after use. Children under 14 years of age consult a physician.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Purpose:

Salicylic Acid 1%..........................Analgesic

Uses:

OTC - PURPOSE SECTION

Uses: For temporary relief of pain associated with cancker sores.

Alcohol Warning:

WARNINGS SECTION

Alcohol Warning: If you consume 3 or more alcoholic drinks everyday, consult with a specialist whether you should use Salicylic Acid or other pain reliver, fever reducers, Salicylic Acid may cause stomach bleeding.

Allergy Alert

WARNINGS AND PRECAUTIONS SECTION

Allergy Alert: May cause a sever allergic reaction which may include: hives, facial swelling, asthma (wheezing), shock.

Flammable

WARNINGS SECTION

Flammable: Keep away from fire or flame.

Do not use for

OTC - DO NOT USE SECTION

Do not use for: Teething, in children under 2 years of age

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children: Incase of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: Use child resistant dropper. children 14 years of age to adult. Apply 2 drops 2 times a day to affected area of the mouth, gums or mucous membranes (throat). Do not rinse mouth after use. Children under 14 years of age consult a physician.

Directions

INDICATIONS & USAGE SECTION

Directions: Use child resistant dropper. children 14 years of age to adult. Apply 2 drops 2 times a day to affected area of the mouth, gums or mucous membranes (throat). Do not rinse mouth after use. Children under 14 years of age consult a physician.

Other Information

OTHER SAFETY INFORMATION

Other Information:

Store at controlled room temperature: 15-30°C (15-86°F).

Tamper Evident Feature: Do not use if cello-band over cap is torn, brocken or missing. Close tightly after use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients: Alcohol, Propylene glycol, Rhubarb Extract, Water

Healthy Lips

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Healthy LipsHealthy LipsVita Mex USA

Dentarin

Healthy Lips

For Cancker & Mouth Sores

(Aftas & Fuegos)

Salicylic Acid 1%

Net Cont. 0.5fl os (15mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1047362salicylic acid 1 % Topical SolutionPSN1
1047362salicylic acid 10 MG/ML Topical SolutionSCD1
1047362salicylic acid 1 % Topical SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69469-012-05Healthy Lips15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69469-012HEALTHY LIPS (SALICYLIC ACID) SOLUTION/ DROPS [VITAMEX USA, CORP]11 package rows20241122_26f68728-28cc-d0a1-e063-6394a90a83e4.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69469-01269469-012-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
RHUBARBG280W4MW6EIACT

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
26f68728-28cd-d0a1-e063-6394a90a83e426f68728-28cc-d0a1-e063-6394a90a83e42024-11-15WarningsExact identifier
spl id: 26f68728-28cd-d0a1-e063-6394a90a83e4
spl set id: 26f68728-28cc-d0a1-e063-6394a90a83e4

Reported adverse events (FAERS/openFDA)#

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