GRAHAMS NATURAL ECZEMA GEL- allantoin gel 
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 Ingredients

Allantoin 0.8%

Purpose

Eczema, insect bites, minor cuts and burns

Keep out of reach of children

Uses/Indications

For the relief of the symptoms of eczema, insect bites, minor cuts and burns

Directions

Apply to affected area as needed or as directed by a doctor

Warnings for external use only

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

Do not use on

Grahams Natural Eczema Gel

For the relief of eczema, insect bites, minor cuts and burns. 

Natural soothing ingredients of comfrey, aloe vera, calendula, manuka honey.

Nature at its Best

Grahams Natural Eczema Gel is a soothing gel formulated for the relief of Eczema using natural ingredients of comfrey, aloe vera, calendula, along with the healing qualities of manuka honey

steroid and fragrance free

Other Information

Store below 86F or 30C

For best results use with Grahams Natural Bath Oil

Questions  www.itchy.net.au

Made in Australia

Grahams Natural Alternatives Pty Ltd

7 Palings Crt, Nerang, QLD 4211 Australia

Inactive Ingredients

aloe barbadensis leaf, aqua, manuka honey, centella asiatica, calendula, hamamelis virginiana leaf, matricaria recutita flower, polysorbate, phenoxyethanol, carbomer, potassium hydroxide.

label image

GRAHAMS NATURAL ECZEMA GEL 
allantoin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42387-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
HONEY (UNII: Y9H1V576FH)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42387-300-0157 g in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/26/2015
Labeler - Grahams Natural Alternatives Pty Ltd (742235419)
Establishment
NameAddressID/FEIBusiness Operations
Grahams Natural Alternatives Pty Ltd742235419manufacture(42387-300)

Revised: 8/2015
Document Id: c1e9b13d-27c7-4fc5-9a0a-7cf14ee8f81c
Set id: c563802d-a880-420f-b8ef-746b98300dd1
Version: 1
Effective Time: 20150826
 
Grahams Natural Alternatives Pty Ltd