PAINZONE- external analgesic cream 
MedZone Products LLC

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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PainZone

Active Ingredients

Camphor 3%

Menthol 12%

Methyl Salicylate 20%

Purpose

Analgesic

Counterirritant

Counterirritant

Uses

Temporarily relieves minor aches and pains of muscle and joints associated with strains, sprains, arthritis, simple backache.

Provides pentrating pain relief.

Warnings

For external use only.Back panel

When using this product

  • do not get into eyes

Stop use and ask a physician if

  • Allergic reaction occurs
  • Condition worsens or does not improve within 7 days
  • Symptoms clear up and return within a few days
  • Redness, irritation, swelling, pain or other symptoms begin or increase

Do not

  • Use in or near the eyes
  • Use in large quantities, particularly over raw surfaces or blistered areas

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center immediately.

Directions

Adults and children 2 years of age and older: Apply to affected area no more than 3 to 4 times daily. Children under 2 years of age: consult a physician.

Other Information

Store at room temperature. Avoid excessive heat or cold.

Inactive Ingredients

Aloe Vera Leaf, Glycerin, Jojoba Oil, Oleic Acid, Polyethylene Glycol 400, Silica, Tea Tree Oil

Questions?

Toll-Free 866-MEDZONE (866-633-9663)

www.medzonecorp.com info@medzonecorp.com

Distributed by MedZone Products LLC

Lenexa, Kansas 66215 All Rights Reserved

3 oz label1 oz label 1 oz label

PAINZONE 
external analgesic cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70338-641
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR, (-)- (UNII: 213N3S8275) (CAMPHOR, (-)- - UNII:213N3S8275) CAMPHOR, (-)-30 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL120 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
JOJOBA OIL (UNII: 724GKU717M)  
OLEIC ACID (UNII: 2UMI9U37CP)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TEA TREE OIL (UNII: VIF565UC2G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70338-641-123.6 g in 1 POUCH; Type 0: Not a Combination Product07/01/2016
2NDC:70338-641-3088 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product09/30/2016
3NDC:70338-641-1028 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product09/30/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/01/2016
Labeler - MedZone Products LLC (080083739)
Registrant - Richard Hamer Associates LLC (067731889)
Establishment
NameAddressID/FEIBusiness Operations
Biomed Laboratories LLC055329696pack(70338-641) , manufacture(70338-641)
Establishment
NameAddressID/FEIBusiness Operations
MicroConsult Inc062183608analysis(70338-641)
Establishment
NameAddressID/FEIBusiness Operations
Ceutical Laboratories Inc789485153analysis(70338-641)

Revised: 2/2018
Document Id: 6507bf97-6250-234b-e053-2991aa0a2d18
Set id: 3773fe01-2206-206c-e054-00144ff88e88
Version: 4
Effective Time: 20180212
 
MedZone Products LLC