drug facts

drug facts
SPL v4
SPL
SPL Set ID 0c89bfec-48b9-4d48-9e03-f9324447de0c
Route
topical
Published
Effective Date 2019-08-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (13 g)
Inactive Ingredients
scutellaria baicalensis root yellow wax cinnamon oil daemonorops draco resin glycyrrhiza uralensis whole peppermint oil petrolatum stearic acid camellia oil paraffin

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2017-05-25

Description

Active ingredients Menthol 13%


Medication Information

Warnings and Precautions

Warnings

For external use only

Active Ingredient

Active ingredients

Menthol 13%

Indications and Usage



Uses

For the temporary relief of minor aches and pains of muscles and joints due to:

simple backache

arthritis

strains

bruises

sprains

Dosage and Administration

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: Do not use, consult your doctor.

Description

Active ingredients Menthol 13%

Section 44425-7

Other information

keep container tightly closed

store at 15 to 30C (59 to 86F)

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

condition worsens

symptoms persist for more than 7 days

symptoms clear up and occur again within a few days

when using for pain of arthritis if:

     pain persists for more than 10 days

     redness is present

     in conditions affecting children under 12 years of age

Section 50567-7

When using this product

avoid contact with the eyes

do not bandage tightly

Section 50570-1

Do not use

on wounds

on damaged skin

if excessive irritation develops

Section 51727-6

Inactive ingredients

BaikaL Skullcap (Huang-Qin) Root, Beeswax, Cinnamon Oil, Dragon's Blood (Xue-Jie) Resin, Licorice (Gan-Zao) Root, Peppermint Oil, Petrolatum, Stearic Acid, Tea Oil and White Paraffin Wax.

Section 51945-4

PO SUM ON HEALING BALM

NDC 54155-053-03

0.35 oz (10g)

Section 53413-1

Questions or comments? (888)221-3496 M-F 9am to 5pm

you may also report serious side effects to this phone number

Section 55105-1

Purpose

External analgesic


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only

Active Ingredient (55106-9)

Active ingredients

Menthol 13%

Indications and Usage (34067-9)



Uses

For the temporary relief of minor aches and pains of muscles and joints due to:

simple backache

arthritis

strains

bruises

sprains

Dosage and Administration (34068-7)

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: Do not use, consult your doctor.

Section 44425-7 (44425-7)

Other information

keep container tightly closed

store at 15 to 30C (59 to 86F)

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

condition worsens

symptoms persist for more than 7 days

symptoms clear up and occur again within a few days

when using for pain of arthritis if:

     pain persists for more than 10 days

     redness is present

     in conditions affecting children under 12 years of age

Section 50567-7 (50567-7)

When using this product

avoid contact with the eyes

do not bandage tightly

Section 50570-1 (50570-1)

Do not use

on wounds

on damaged skin

if excessive irritation develops

Section 51727-6 (51727-6)

Inactive ingredients

BaikaL Skullcap (Huang-Qin) Root, Beeswax, Cinnamon Oil, Dragon's Blood (Xue-Jie) Resin, Licorice (Gan-Zao) Root, Peppermint Oil, Petrolatum, Stearic Acid, Tea Oil and White Paraffin Wax.

Section 51945-4 (51945-4)

PO SUM ON HEALING BALM

NDC 54155-053-03

0.35 oz (10g)

Section 53413-1 (53413-1)

Questions or comments? (888)221-3496 M-F 9am to 5pm

you may also report serious side effects to this phone number

Section 55105-1 (55105-1)

Purpose

External analgesic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)