SPL v7
SPL
SPL Set ID 1b869a1f-5787-4d03-a546-43a8217b2b2c
Route
TOPICAL
Published
Effective Date 2015-05-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.5 g)
Inactive Ingredients
Isopropyl Alcohol Methyl Salicylate Eucalyptus Oil Spearmint Oil Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-05-19

Description

Topical Burn Cream Plus Pain Relief

Purpose

Pain & Itch Relief For the temporary relief of minor aches and pains of muscles and joints commonly associated with backache, arthritis, strains, bruises, and sprains.


Medication Information

Purpose

Pain & Itch Relief

For the temporary relief of minor aches and pains of muscles and joints commonly associated with backache, arthritis, strains, bruises, and sprains.

Description

Topical Burn Cream Plus Pain Relief

Section 51945-4

Warnings

Not intended for use on children under 2 years old except as directed by a doctor.

Avoid contact with eyes.

For external use only.

If irritation develops and persists, discontinue use and consult a doctor.

If condition worsens or if symptoms persist more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.

Directions

Apply this product topically to affected areas and allow to dry without rubbing.

Use as often as needed.

Use only as directed.

Drug Facts

Topical Burn Cream Plus Pain Relief

Indications

For cooling, deep-penetrating pain relief, spray Novum APR generously on the skin around aching joints or muscle pain and allow to dry without rubbing.

Apply as often as needed.

Active Ingredient

Menthol 0.5%

Other Information

External analgesic

Inactive Ingredients

ISOPROPYL ALCOHOL, PURIFIED WATER, METHYL SALICYLATE, EUCALYPTUS ESSENTIAL OIL, SPEARMINT ESSENTIAL OIL.

Questions Or Comments

​Novum Solutions, Inc.

1585 West Sam Houston Pkwy N, #820

Houston, TX 77403

www.NovumSolutions.com

CALL 832-200-8005

FAX 713-464-6319

​keep Out of Reach of Children

​KEEP OUT OF REACH OF CHILDREN


Structured Label Content

Section 51945-4 (51945-4)

Purpose

Pain & Itch Relief

For the temporary relief of minor aches and pains of muscles and joints commonly associated with backache, arthritis, strains, bruises, and sprains.

Warnings

Not intended for use on children under 2 years old except as directed by a doctor.

Avoid contact with eyes.

For external use only.

If irritation develops and persists, discontinue use and consult a doctor.

If condition worsens or if symptoms persist more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.

Directions

Apply this product topically to affected areas and allow to dry without rubbing.

Use as often as needed.

Use only as directed.

Drug Facts

Topical Burn Cream Plus Pain Relief

Indications

For cooling, deep-penetrating pain relief, spray Novum APR generously on the skin around aching joints or muscle pain and allow to dry without rubbing.

Apply as often as needed.

Active Ingredient

Menthol 0.5%

Other Information

External analgesic

Inactive Ingredients

ISOPROPYL ALCOHOL, PURIFIED WATER, METHYL SALICYLATE, EUCALYPTUS ESSENTIAL OIL, SPEARMINT ESSENTIAL OIL.

Questions Or Comments (Questions or Comments)

​Novum Solutions, Inc.

1585 West Sam Houston Pkwy N, #820

Houston, TX 77403

www.NovumSolutions.com

CALL 832-200-8005

FAX 713-464-6319

​keep Out of Reach of Children (​KEEP OUT OF REACH OF CHILDREN)

​KEEP OUT OF REACH OF CHILDREN


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)