Grahams Natural Diaper Rash (Zinc Oxide) Cream [Grahams Natural Alternatives Pty Ltd] -

GRAHAMS NATURAL DIAPER RASH (ZINC OXIDE) CREAM [GRAHAMS NATURAL ALTERNATIVES PTY LTD]
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NDC	42387-135-01
Set ID	382b2771-99a4-5863-e054-00144ff8d46c
Category	HUMAN OTC DRUG LABEL
Packager	Grahams Natural Alternatives Pty Ltd
Generic Name
Product Class
Product Number
Application Number	PART347

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ACTIVE INGREDIENT

ACTIVE INGREDIENT

Zinc Oxide 12%
PURPOSE

PURPOSE

Skin Protectant
KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children
INDICATIONS & USAGE

Uses and Indications

For the relief of diaper rash, minor cuts and burns
DOSAGE & ADMINISTRATION

Directions

Apply cream, liberally, and as often as necessary to dry skin, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
WARNINGS

Warnings

For external use only

Avoider contact with eyes. If any adverse reaction develops, stop use, and contact a physician.
QUESTIONS

Questions

www.itchy.net.au

Made in Australia

Grahams Natural Alternatives Pty Ltd

7 Palings Crt, Nerang, QLD 4211 Australia
INACTIVE INGREDIENT

Inactive Ingredients

Purified Water, Betaine,
Glycerin, Cetearyl Alcohol, Glyceryl Stearate SE, Coco-
Caprylate, Prunus Amygdalus Dulcis (Sweet Almond) Oil),
Helianthus Annuus (Sunflower) Seed Oil, Butyrospermum
Parkii (Shea Butter), Beeswax, Caprylic/Capric
Triglyceride, Sodium Stearoyl Glutamate, Jojoba Oil,
Xanthan Gum, Chamomile Extract, Calendula Extract,
Tocopherol Acetate, Phenoxyethanol, Capryl Glycol
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GRAHAMS NATURAL DIAPER RASH
zinc oxide cream

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	12 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
JOJOBA OIL (UNII: 724GKU717M)
CHAMOMILE (UNII: FGL3685T2X)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
WATER (UNII: 059QF0KO0R)
YELLOW WAX (UNII: 2ZA36H0S2V)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
COCO-CAPRYLATE (UNII: 4828G836N6)
ALMOND OIL (UNII: 66YXD4DKO9)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SHEA BUTTER (UNII: K49155WL9Y)
XANTHAN GUM (UNII: TTV12P4NEE)
CALENDULA ARVENSIS LEAF (UNII: 3U3U118F2L)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
SODIUM LEVULINATE (UNII: VK44E1MQU8)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42387-135-01	73 g in 1 TUBE; Type 0: Not a Combination Product	07/21/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	07/21/2016

Labeler - Grahams Natural Alternatives Pty Ltd (742235419)

Name	Address	ID/FEI	Business Operations
Establishment
Grahams Natural Alternatives Pty Ltd		742235419	manufacture(42387-135)

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