GRAHAMS NATURAL DIAPER RASH- zinc oxide cream 
Grahams Natural Alternatives Pty 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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ACTIVE INGREDIENT

Zinc Oxide 12%

PURPOSE

Skin Protectant

Keep out of reach of children

Uses and Indications

For the relief of diaper rash, minor cuts and burns

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 

For external use only

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



Questions 

www.itchy.net.au

Made in Australia

Grahams Natural Alternatives Pty Ltd

7 Palings Crt, Nerang, QLD 4211 Australia

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

back labelFront Label

GRAHAMS NATURAL DIAPER RASH 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42387-135
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42387-135-0173 g in 1 TUBE; Type 0: Not a Combination Product07/21/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/21/2016
Labeler - Grahams Natural Alternatives Pty Ltd (742235419)
Establishment
NameAddressID/FEIBusiness Operations
Grahams Natural Alternatives Pty Ltd742235419manufacture(42387-135)

Revised: 8/2016
Document Id: 382b84d8-6c03-24ca-e054-00144ff88e88
Set id: 382b2771-99a4-5863-e054-00144ff8d46c
Version: 1
Effective Time: 20160830
 
Grahams Natural Alternatives Pty Ltd