4JOINTZ- eucalyptus oil, tannic acid, allantoin cream
ARP(USA) 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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4Jointz

Drug Facts - Active Ingredients

Eucalyptus Oil 4%

Tannic Acid 5%

Allantoin (from Comfrey) 0.025%

Drug Facts - Purpose

Eucalyptus Oil - Topical analgesic

Tannic Acid - Skin protectant

Allantoin - Skin protectant

Uses

Temporarily relieves the aches and pains of muscles and joints associated with:

arthritis
simple backache
strains
bruises
sprains

Warnings

For external use only.

Do not use

on open wounds or damaged skin
on a child under 12 years of age with arthritis-like conditions
near the eyes

Ask a doctor if

conditions worsen
symptoms clear up and occur again in a few days
redness or irritation develops

Keep out of the reach of children

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Use only as directed

adults & children 12 years and older: massage gently into affected joints
apply three (3) times daily for optimal results

Other Information

Store below 30°C (86°F)

Manufactured for ARP (USA) Pty Ltd, 2A, Ground Floor, 15 Lake St.

Varsity Lakes QLD 4227 Australia. Visit www.4Jointz.com for further

details and to see how 4Jointz has helped people just like you.

Patent: www.4jointz.com/patent

Inactive Ingredients

purified water, organic aloe vera gel, urea, cetyl alcohol, denatured alcohol, glyceryl stearate, olive oil, propylene glycol, PEG 100 stearate, glycerin USP, N-methyl-2-pyrrolidone, trisiloxane, casto oil, frankincense oil, xanthan gum, tetrahydropiperine, polydimethylsiloxane, methylisothiazolinone & phenethyl alcohol, methyl paraben, propyl paraben, sodium hydroxide

4Jointz

Live Pain Free!

4JOINTZ

FREEDOM TO MOVE

Pain Relief Cream

www.4Jointz.com

2 x 3.5 oz (100g) tubes - 7oz (200g) total

Principal Display Panel

4JOINTZ
eucalyptus oil, tannic acid, allantoin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71282-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TANNIC ACID (UNII: 28F9E0DJY6) (TANNIC ACID - UNII:28F9E0DJY6)	TANNIC ACID	5 g in 100 g
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.025 g in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CASTOR OIL (UNII: D5340Y2I9G)
TETRAHYDROPIPERINE (UNII: 8904DO502T)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
UREA (UNII: 8W8T17847W)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
FRANKINCENSE OIL (UNII: 67ZYA5T02K)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-100 STEARATE (UNII: YD01N1999R)
METHYL PYRROLIDONE (UNII: JR9CE63FPM)
TRISILOXANE (UNII: 9G1ZW13R0G)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
OLIVE OIL (UNII: 6UYK2W1W1E)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71282-001-07	100 g in 1 TUBE; Type 0: Not a Combination Product	01/31/2017	04/05/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	01/31/2017	04/05/2018

Labeler - ARP(USA) Pty Ltd (744244375)

Name	Address	ID/FEI	Business Operations
Establishment
Sarati International, Inc.		160219770	manufacture(71282-001)

Revised: 4/2018

Document Id: 6a68310e-1fe4-407d-bbd2-29a2ea063b52

Set id: 47546864-4839-6aef-e054-00144ff88e88

Version: 3

Effective Time: 20180405

ARP(USA) Pty Ltd