GRAHAMS NATURAL DIAPER RASH- zinc oxide cream

Grahams Natural Diaper Rash by

Drug Labeling and Warnings

Grahams Natural Diaper Rash by is a Otc medication manufactured, distributed, or labeled by Grahams Natural Alternatives Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42387-135
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Grahams Natural Alternatives Pty Ltd (742235419)

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