Zepol Topical Analgesic

Dosage form: ointment
Ingredients: CAMPHOR (SYNTHETIC) 6.55g in 100g, MENTHOL 6.55g in 100g
Labeler: Laboratorios Zepol S.A.
NDC code: 55715-001

Medically reviewed by Drugs.com. Last updated on Oct 14, 2024.

Zepol Topical Analgesic Ointment

Drug Facts

Active Ingredients

Camphor 6.55%
Menthol 6.55%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, strains, bruises and sprains.

Warnings

For external use only.
Avoid contact with eyes.
If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

Do not apply

to wounds or damaged skin.
Do not bandage tightly.

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

Directions:

-Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. -Children under 2 years of age: Consult a physician.

Other information

Store at 30 degrees C (86 degrees F).

Inactive Ingredients

Eucalyptol, Petrolatum, Thyme Oil, Turpentine Oil Rectified.

Package Labeling:

Zepol Topical Analgesic Ointment,12 units (0.35oz/10g) (55715-001-12)

ZEPOL TOPICAL ANALGESIC
camphor, menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55715-001
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC))	CAMPHOR (SYNTHETIC)	6.55 g in 100 g
MENTHOL (MENTHOL)	MENTHOL	6.55 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
EUCALYPTOL
PETROLATUM
TURPENTINE
THYME OIL

Packaging
#	Item Code	Package Description
1	NDC:55715-001-01	30 g in 1 TUBE
2	NDC:55715-001-90	1 TUBE in 1 BOX
2		90 g in 1 TUBE
3	NDC:55715-001-12	12 CAN in 1 BOX
3		10 g in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/05/2009

Labeler - Laboratorios Zepol S.A. (853070985)

Establishment
Name	Address	ID/FEI	Operations
Laboratorios Zepol S.A		853070985	manufacture(55715-001)

Revised: 10/2019

Document Id: 957cfffb-8852-6e4c-e053-2a95a90a2e2d

Set id: ca20ade6-9b35-40bb-b3b2-fc3a0e1eece9

Version: 5

Effective Time: 20191022

Laboratorios Zepol S.A.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer