83781-010 Updete V2

83781-010 Updete V2
SPL v2
SPL
SPL Set ID 1f878abd-54cd-1963-e063-6294a90a1884
Route
TOPICAL
Published
Effective Date 2025-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (2 g) Camphor (synthetic) (1.5 g) Borneol (1.2 g)
Inactive Ingredients
Angelica Biserrata Whole Frankincense Myrrh Angelicin Trachelospermum Jasminoides Stem European Elderberry Drynaria Fortunei Root Safflower

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-13

Description

Menthol 2.0% Borneol 1.2% Camphor 1.5%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 2.0% Borneol 1.2% Camphor 1.5%

Use

Target User: for sub healthy people with discomfort caused by neck, shoulder,waist and leg.

Stop Use

Stop use and ask doctor if:

■ rash, itching or excessive skin irritation develops

■ condition worsens

■ symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days If pregnant or breastfeeding, ask a health professional before use

■ Keep out of reach of children

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

Warnings

For external use only.

Questions

Questions or comments?

Email: [email protected]

Ask Doctor

Stop use and ask doctor if:

■ rash, itching or excessive skin irritation develops

■ condition worsens

■ symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days If pregnant or breastfeeding, ask a health professional before use

■ Keep out of reach of children

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

Directions

adults and children over 12 years:

■clean and dry the affected area

■remove backing from patch and apply patch to affected area

■use 1 patch per knee for 8 to 12 hours, once per day

children 12 years or younger: ask a doctor

Do Not Use

When using this product

■ use only as directed

■ do not bandage tighty or use with a heating pad

■ avoid contact with eyes and mucous membranes

■ do not apply to wounds or damaged, broken or imitated skin

■ do not use at the same time as other topical analgesics

When Using

When using this product

■ use only as directed

■ do not bandage tighty or use with a heating pad

■ avoid contact with eyes and mucous membranes

■ do not apply to wounds or damaged, broken or imitated skin

■ do not use at the same time as other topical analgesics

Active Ingredient

Menthol 2.0%

Borneol 1.2%

Camphor 1.5%

Other Information

store at room temperature, not to exceed 86°F (30°C)

Inactive Ingredients

Radix Angelicae Pubescentis, Drynaria Rhizome, Myrrh, Frankincense, Elderberry, Safflower, Angelicae, and Trachlospermi Caulis Et Folium

Principal Display Panel

Keep Out of Reach of Children

■ Keep out of reach of children


Structured Label Content

Use

Target User: for sub healthy people with discomfort caused by neck, shoulder,waist and leg.

Purpose

Topical Analgesic

Stop Use

Stop use and ask doctor if:

■ rash, itching or excessive skin irritation develops

■ condition worsens

■ symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days If pregnant or breastfeeding, ask a health professional before use

■ Keep out of reach of children

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

Warnings

For external use only.

Questions

Questions or comments?

Email: [email protected]

Ask Doctor

Stop use and ask doctor if:

■ rash, itching or excessive skin irritation develops

■ condition worsens

■ symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days If pregnant or breastfeeding, ask a health professional before use

■ Keep out of reach of children

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

Directions

adults and children over 12 years:

■clean and dry the affected area

■remove backing from patch and apply patch to affected area

■use 1 patch per knee for 8 to 12 hours, once per day

children 12 years or younger: ask a doctor

Do Not Use (Do not use)

When using this product

■ use only as directed

■ do not bandage tighty or use with a heating pad

■ avoid contact with eyes and mucous membranes

■ do not apply to wounds or damaged, broken or imitated skin

■ do not use at the same time as other topical analgesics

When Using

When using this product

■ use only as directed

■ do not bandage tighty or use with a heating pad

■ avoid contact with eyes and mucous membranes

■ do not apply to wounds or damaged, broken or imitated skin

■ do not use at the same time as other topical analgesics

Active Ingredient

Menthol 2.0%

Borneol 1.2%

Camphor 1.5%

Other Information (Other information)

store at room temperature, not to exceed 86°F (30°C)

Inactive Ingredients (Inactive ingredients)

Radix Angelicae Pubescentis, Drynaria Rhizome, Myrrh, Frankincense, Elderberry, Safflower, Angelicae, and Trachlospermi Caulis Et Folium

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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)