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

Description

Borneol 1.2% Camphor 1.5%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Borneol 1.2% Camphor 1.5%

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

Warnings

For external use only.

Questions
Ask Doctor

children 12 years or younger

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

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%

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.

Principal Display Panel

Keep Out of Reach of Children

Keep Out Of Reach Of Children


Structured Label Content

Use

temporarily relieves minor pain associated with:

■arthritis

■muscle strains

■sprains

■bruises

■ joint pain

Purpose

Topical Analgesic

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

Warnings

For external use only.

Questions
Ask Doctor

children 12 years or younger

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

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%

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)

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)