PainZone

Manufacturer: MedZone Products LLC | Richard Hamer Associates LLC | Biomed Laboratories LLC | MicroConsult Inc | Ceutical Laboratories Inc
Effective date: 2018-02-12
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 22:54:28

Label at a glance#

ProductPainZone

Active ingredientCAMPHOR, (-)-, MENTHOL, METHYL SALICYLATE

Label structure10 sections

Indications and uses

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

Dosage and administration

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.

Contacts and useful links#

PhoneLabel contact(866-633-9663

Websitewww.medzonecorp.com

www.medzonecorp.com

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 3%

Menthol 12%

Methyl Salicylate 20%

Purpose

OTC - PURPOSE SECTION

Analgesic

Counterirritant

Uses

INDICATIONS & USAGE SECTION

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

Provides pentrating pain relief.

Warnings

WARNINGS SECTION

For external use only.Back panel

When using this product

OTC - WHEN USING SECTION

do not get into eyes

Stop use and ask a physician if

OTC - STOP USE SECTION

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

OTC - DO NOT USE SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

Store at room temperature. Avoid excessive heat or cold.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

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

www.medzonecorp.com info@medzonecorp.com

HOW SUPPLIED SECTION

Distributed by MedZone Products LLC

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3 oz label1 oz label1 oz label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1999325	camphor 3 % / menthol 12 % / methyl salicylate 20 % Topical Cream	PSN	4
1999325	camphor 30 MG/ML / menthol 120 MG/ML / methyl salicylate 200 MG/ML Topical Cream	SCD	4
1999325	camphor 3 % / menthol 12 % / methyl salicylate 20 % Topical Cream	SY	4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70338-641-10	2023-07-28	C162847	48780-1	0191ceaa-6163-198a-e063-dbdaa90aec3e	PainZone
70338-641-12	2023-07-28	C162847	48780-1	0191ceaa-6163-198a-e063-dbdaa90aec3e	PainZone
70338-641-30	2023-07-28	C162847	48780-1	0191ceaa-6163-198a-e063-dbdaa90aec3e	PainZone

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70338-641-10	PainZone	28 g in 1 BOTTLE, WITH APPLICATOR	CREAM	28	4
70338-641-12	PainZone	3.6 g in 1 POUCH	CREAM	3.6	4
70338-641-30	PainZone	88 g in 1 BOTTLE, WITH APPLICATOR	CREAM	88	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70338-641	PAINZONE (EXTERNAL ANALGESIC) CREAM [MEDZONE PRODUCTS LLC]	4	Legacy NDC, 3 package rows	20180212_3773fe01-2206-206c-e054-00144ff88e88.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

PainZone
External Analgesic
CAMPHOR, (-)-
MENTHOL
METHYL SALICYLATE
SALICYLIC ACID
ALOE VERA LEAF
GLYCERIN
JOJOBA OIL
OLEIC ACID
POLYETHYLENE GLYCOL 400
SILICON DIOXIDE
TEA TREE OIL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70338-641	70338-641-12, 70338-641-30, 70338-641-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CAMPHOR, (-)-	213N3S8275	ACTIB
MENTHOL	L7T10EIP3A	ACTIB
METHYL SALICYLATE	LAV5U5022Y	ACTIB
ALOE VERA LEAF	ZY81Z83H0X	IACT
GLYCERIN	PDC6A3C0OX	IACT
JOJOBA OIL	724GKU717M	IACT
OLEIC ACID	2UMI9U37CP	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
TEA TREE OIL	VIF565UC2G	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
6507bf97-6250-234b-e053-2991aa0a2d18			3773fe01-2206-206c-e054-00144ff88e88	2018-02-12	Warnings	Exact identifier spl id: 6507bf97-6250-234b-e053-2991aa0a2d18 spl set id: 3773fe01-2206-206c-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.