OLIVENE  DIAPER RASH- zinc oxide ointment 
Fischer Pharmaceuticlas Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Olivene®
Diaper Rash

Drug Facts

Active Ingredients

Zinc Oxide 40%

Purpose

Skin Protectant

Uses

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

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

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

Principal Display Panel - 113 g. Tube Carton
OLIVENE   DIAPER RASH
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59886-413
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide400 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59886-413-991 in 1 CARTON01/11/2013
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34701/11/2013
Labeler - Fischer Pharmaceuticlas Ltd. (600158976)
Establishment
NameAddressID/FEIBusiness Operations
Fischer Pharmaceuticals Ltd.600410514MANUFACTURE(59886-413)

Revised: 6/2016
Document Id: ea906a2b-f6fd-43ec-abc1-3f3187475c22
Set id: 4378730e-da7b-401b-bd24-b8e853bd8d2d
Version: 2
Effective Time: 20160609
 
Fischer Pharmaceuticlas Ltd.