Pure Baby Diaper Rash (Zinc Oxide) Cream [Fischer Pharmaceuticals Ltd] -

PURE BABY DIAPER RASH (ZINC OXIDE) CREAM [FISCHER PHARMACEUTICALS LTD]
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NDC	59886-414-32
Set ID	8c0cbb66-38aa-4429-a6a0-6c063131296a
Category	HUMAN OTC DRUG LABEL
Packager	Fischer Pharmaceuticals Ltd
Generic Name
Product Class
Product Number
Application Number	PART347

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SPL UNCLASSIFIED SECTION

Drug Facts
Active Ingredients

Zinc Oxide 12%
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 cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged.
Inactive Ingredients

Bisabolol, Calendula Officinalis Flower Extract, Caprylic/Capric Triglyceride, Coco-Caprylate, Dunaliella Salina Extract, Ethylhexylglycerin, Globularia Alypum Leaf Extract, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Castor Oil, Magnesium Sulfate, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-3 Diisostearate, Potassium Sorbate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sodium Benzoate, Tocopherol, Water.
Questions or Comments?

Call 1-888-553-6112 Mon-Fri
SPL UNCLASSIFIED SECTION

Manufactured by:
Fischer Pharmaceuticals Ltd.
Tel Aviv, POB 39071, Israel.
PRINCIPAL DISPLAY PANEL - 113 g Tube Label

Dr. Fischer®

Pure
baby

Diaper Rash Cream

100%
ORGANIC OILS

Helps Treat &
Prevent

With
Natural
Origin Ingredients

SCIENCE INSIDE
- SCIENCE INSIDE -

Hypoallergenic • Sensitive Tested

NO
Fragrance, Parabens, SLS, SLES,
Lanolin, Silicones, Paraffin, GMOs

Net Wt. 4 oz. (113 g.)

FISCHER PHARMACEUTICALS

INGREDIENTS AND APPEARANCE

PURE BABY DIAPER RASH
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59886-414
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	40 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
LEVOMENOL (UNII: 24WE03BX2T)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Coco-Caprylate (UNII: 4828G836N6)
DUNALIELLA SALINA (UNII: F4O1DKI9A6)
Ethylhexylglycerin (UNII: 147D247K3P)
GLOBULARIA CORDIFOLIA WHOLE (UNII: SD327VQ78H)
Glycerin (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
Hydrogenated Castor Oil (UNII: ZF94AP8MEY)
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
OLIVE OIL (UNII: 6UYK2W1W1E)
Phenoxyethanol (UNII: HIE492ZZ3T)
Polyglyceryl-2 Dipolyhydroxystearate (UNII: 9229XJ4V12)
Polyglyceryl-3 Diisostearate (UNII: 46P231IQV8)
Potassium Sorbate (UNII: 1VPU26JZZ4)
ALMOND OIL (UNII: 66YXD4DKO9)
Sodium Benzoate (UNII: OJ245FE5EU)
Tocopherol (UNII: R0ZB2556P8)
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59886-414-32	113 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part347	01/01/2018

Labeler - Fischer Pharmaceuticals Ltd (600158976)

Name	Address	ID/FEI	Business Operations
Establishment
Fischer Pharmaceuticals Ltd		600410514	MANUFACTURE(59886-414)

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Medic

PURE BABY DIAPER RASH (ZINC OXIDE) CREAM [FISCHER PHARMACEUTICALS LTD]

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