OLIVENE DIAPER RASH- zinc oxide ointment

Olivene by

Drug Labeling and Warnings

Olivene by is a Otc medication manufactured, distributed, or labeled by Fischer Pharmaceuticlas Ltd., Fischer Pharmaceuticals Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Zinc Oxide 40%

Purpose

Skin Protectant

Uses

• Helps treat and prevent diaper rash
• Protects chafed skin due to diaper rash and helps seal out wetness.

Warnings

For external use only.

When using this product avoid contact with the eyes.

Stop use and ask a doctor if condition worsens or lasts more than 7 days.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Change wet and solid diapers promptly
• Clean the diaper area and allow to dry
• Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged.

Other Information

Store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

Water (Aqua), Mineral Oil, Petrolatum, Beeswax, Lanolin, Olea Europaea (Olive) Oil Unsaponifiables, Oleyl Erucate, Sorbitan Isostearate, DMDM Hydantoin, Glycyrrhetinic Acid, Propylene Glycol, BHT, Ascorbyl Palmitate, Glyceryl Stearate, Citric Acid.

Questions or Comments?

Call 1-888-553-6112 Mon-Fri

SPL UNCLASSIFIED SECTION

Manufactured by: Fischer Pharmaceuticals LTD.
Bnei Brak 51553, Israel

PRINCIPAL DISPLAY PANEL - 113 g. Tube Carton

MAXIMUM
STRENGTH

Dr. Fischer®

NATURE BABY

Olivene®
Diaper Rash Ointment

Rash Fighting
40% Zinc Oxide & Soothing
Olive Oil, Beeswax & Licorice

Rapid Relief

113 g. 4 oz.

FISCHER PHARMACEUTICALS

INGREDIENTS AND APPEARANCE

OLIVENE   DIAPER RASH
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59886-413
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	400 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Mineral Oil (UNII: T5L8T28FGP)
Petrolatum (UNII: 4T6H12BN9U)
Yellow Wax (UNII: 2ZA36H0S2V)
Lanolin (UNII: 7EV65EAW6H)
Olive Oil (UNII: 6UYK2W1W1E)
Oleyl Erucate (UNII: 753W099NQ6)
Sorbitan Isostearate (UNII: 01S2G2C1E4)
DMDM Hydantoin (UNII: BYR0546TOW)
Enoxolone (UNII: P540XA09DR)
Propylene Glycol (UNII: 6DC9Q167V3)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Ascorbyl Palmitate (UNII: QN83US2B0N)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Citric Acid Monohydrate (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59886-413-99	1 in 1 CARTON	01/11/2013
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	01/11/2013

Labeler - Fischer Pharmaceuticlas Ltd. (600158976)

Establishment
Name	Address	ID/FEI	Business Operations
Fischer Pharmaceuticals Ltd.		600410514	MANUFACTURE(59886-413)