HEALTHY LIPS- salicylic acid solution/ drops

Healthy Lips by

Drug Labeling and Warnings

Healthy Lips by is a Otc medication manufactured, distributed, or labeled by VitaMex USA, Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Active Ingredient: Purpose:

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

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

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)

INGREDIENTS AND APPEARANCE

HEALTHY LIPS 
salicylic acid solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69469-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
RHUBARB (UNII: G280W4MW6E)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69469-012-05	15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	11/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	11/15/2024

Labeler - VitaMex USA, Corp (054256676)