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NDC 70338-0641-30 PainZone 30; 120; 200 mg/g; mg/g; mg/g Details

PainZone 30; 120; 200 mg/g; mg/g; mg/g

PainZone is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by MedZone Products LLC. The primary component is CAMPHOR, (-)-; MENTHOL; METHYL SALICYLATE.

Product Information

NDC	70338-0641
Product ID	70338-641_6507bf97-6250-234b-e053-2991aa0a2d18
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	PainZone
Proprietary Name Suffix	n/a
Non-Proprietary Name	External Analgesic
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	30; 120; 200
Active Ingredient Units	mg/g; mg/g; mg/g
Substance Name	CAMPHOR, (-)-; MENTHOL; METHYL SALICYLATE
Labeler Name	MedZone Products LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70338-0641-30 (70338064130)

Pricing Information	N/A
NDC Package Code	70338-641-30
Billing NDC	70338064130
Package	88 g in 1 BOTTLE, WITH APPLICATOR (70338-641-30)
Marketing Start Date	2016-09-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3773fe01-2206-206c-e054-00144ff88e88 Details

Active Ingredients

Camphor 3%

Menthol 12%

Methyl Salicylate 20%

Purpose

Analgesic

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 [email protected]

SPL UNCLASSIFIED SECTION

Distributed by MedZone Products LLC

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/01/2016

Labeler - MedZone Products LLC (080083739)

Registrant - Richard Hamer Associates LLC (067731889)

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

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

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

Revised: 2/2018

Document Id: 6507bf97-6250-234b-e053-2991aa0a2d18

Set id: 3773fe01-2206-206c-e054-00144ff88e88

Version: 4

Effective Time: 20180212