ZEPOL TOPICAL ANALGESIC- camphor, menthol ointment

Zepol Topical Analgesic by

Drug Labeling and Warnings

Zepol Topical Analgesic by is a Otc medication manufactured, distributed, or labeled by Laboratorios Zepol S.A., Laboratorios Zepol S.A. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Package Labeling:

Package Labeling:

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

55715-001-12)

INGREDIENTS AND APPEARANCE

ZEPOL TOPICAL ANALGESIC 
camphor, menthol ointment

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	6.55 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	6.55 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
EUCALYPTOL (UNII: RV6J6604TK)
PETROLATUM (UNII: 4T6H12BN9U)
TURPENTINE (UNII: XJ6RUH0O4G)
THYME OIL (UNII: 2UK410MY6B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55715-001-01	30 g in 1 TUBE; Type 0: Not a Combination Product	10/05/2009
2	NDC: 55715-001-90	1 in 1 BOX	10/05/2009
2		90 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 55715-001-12	12 in 1 BOX	10/01/2019
3		10 g in 1 CAN; Type 0: Not a Combination Product

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	Business Operations
Laboratorios Zepol S.A		853070985	manufacture(55715-001)