Active Ingredient
Active Ingredient: Purpose:
Salicylic Acid 1%..........................Analgesic
Healthy Lips
FDA Label NDC 69469-012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vitamex Usa, Corp for the product Healthy Lips (NDC 69469-012). 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 active ingredient, uses:, alcohol warning:, allergy alert, flammable, do not use for, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses:
Uses: For temporary relief of pain associated with cancker sores.
Alcohol Warning:
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
Allergy Alert: May cause a sever allergic reaction which may include: hives, facial swelling, asthma (wheezing), shock.
Flammable
Flammable: Keep away from fire or flame.
Do Not Use For
Do not use for: Teething, in children under 2 years of age
Keep Out Of Reach Of Children
Keep out of reach of children: Incase of accidental overdose, get medical help or contact a Poison Control Center right away.
Directions
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: 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 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 ingredients: Alcohol, Propylene glycol, Rhubarb Extract, Water
Healthy Lips
Vita Mex USA
Dentarin
Healthy Lips
For Cancker & Mouth Sores
(Aftas & Fuegos)
Salicylic Acid 1%
Net Cont. 0.5fl os (15mL)
* Please review the disclaimer below.
