83781-002 update v3 update pack

83781-002 update v3 update pack
SPL v3
SPL
SPL Set ID 09772e4b-8193-3771-e063-6394a90a9516
Route
topical
Published
Effective Date 2025-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
camphor (synthetic) (1.5 g) borneol (1.2 g)
Inactive Ingredients
artemisia vulgaris top oil cinnamon wormwood osmanthus fragrans flower eucalyptus oil saffron ginger

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-11-05

Purpose

Topical Analgesic

Description

Borneol 1.2% Camphor 1.5%


Medication Information

Warnings

For external use only.

Purpose

Topical Analgesic

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

Other Information

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

Inactive Ingredients

Dried ginger, saffron, Wormwood, mugwort oil, osmanthus flower oil, eucalyptus leaf oil, cinnamon.

Description

Borneol 1.2% Camphor 1.5%

Principal Display Panel

Use

temporarily relieves minor pain associated with:

■arthritis

■muscle strains

■sprains

■bruises

■ joint pain

Stop Use

■ 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

Questions
Ask Doctor

children 12 years or younger

When Using

■ 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

Borneol 1.2%

Camphor 1.5%

Keep Out of Reach of Children

Keep Out Of Reach Of Children


Structured Label Content

Warnings

For external use only.

Purpose

Topical Analgesic

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

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

Dried ginger, saffron, Wormwood, mugwort oil, osmanthus flower oil, eucalyptus leaf oil, cinnamon.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Use

temporarily relieves minor pain associated with:

■arthritis

■muscle strains

■sprains

■bruises

■ joint pain

Stop Use

■ 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

Questions
Ask Doctor

children 12 years or younger

When Using

■ 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

Borneol 1.2%

Camphor 1.5%

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)