PAINZONE- external analgesic cream

PainZone by

Drug Labeling and Warnings

PainZone by is a Otc medication manufactured, distributed, or labeled by MedZone Products LLC, Richard Hamer Associates LLC, Biomed Laboratories LLC, MicroConsult Inc, Ceutical Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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

HOW SUPPLIED

Distributed by MedZone Products LLC

Lenexa, Kansas 66215 All Rights Reserved

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAINZONE 
external analgesic cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70338-641
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR, (-)- (UNII: 213N3S8275) (CAMPHOR, (-)- - UNII:213N3S8275)	CAMPHOR, (-)-	30 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	120 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70338-641-12	3.6 g in 1 POUCH; Type 0: Not a Combination Product	07/01/2016
2	NDC: 70338-641-30	88 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	09/30/2016
3	NDC: 70338-641-10	28 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	09/30/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/01/2016

Labeler - MedZone Products LLC (080083739)

Registrant - Richard Hamer Associates LLC (067731889)

Establishment
Name	Address	ID/FEI	Business Operations
Biomed Laboratories LLC		055329696	pack(70338-641) , manufacture(70338-641)

Establishment
Name	Address	ID/FEI	Business Operations
MicroConsult Inc		062183608	analysis(70338-641)

Establishment
Name	Address	ID/FEI	Business Operations
Ceutical Laboratories Inc		789485153	analysis(70338-641)