SPL v1
SPL
SPL Set ID 3cf1bc74-3060-6d63-e063-6294a90a9f5c
Route
TOPICAL
Published
Effective Date 2025-08-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor, (-)- (2 mg) Menthol (75 mg) Isopropyl Alcohol
Inactive Ingredients
Reynoutria Japonica Whole Rubia Cordifolia Whole Oldenlandia Herbacea Whole Persicaria Perfoliata Whole Houttuynia Cordata Whole Dictamnus Dasycarpus Whole Gentiana Scabra Whole Imperata Cylindrica Root Prunella Vulgaris Sophora Tonkinensis Root Pseudolarix Amabilis Bark Sophora Flavescens Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-13

Description

Camphor(2%)-----External analgesic Menthol(2%)---External analgesic Isopropyl Alcohol(75%)----------- Antiseptic


Medication Information

Warnings and Precautions

For external use only

Flammable: Keep away from heat or flameAvoid contact with eyes .

Stop use and ask a doctor if rash, irritationor symptoms worsen

Keep out of reach of children.

lf swallowedget medical help or contact a Poison Control Center right away

Indications and Usage

Temporarily relieves itching and discomfort from insect bites orminor skin irritations ,Provides mild antibacterial effect for skin

Dosage and Administration

Adults and children 2 years and older: Apply 3 to 4 times daily to the affected area.

Children under 2 years: Ask a doctor.

Description

Camphor(2%)-----External analgesic Menthol(2%)---External analgesic Isopropyl Alcohol(75%)----------- Antiseptic

Section 50565-1

Keep out of reach of children.

Section 51727-6

Sophora tonkinensis, Pseudolaric Bark,Cogongrass RhizomeLobelia chinensis, Reynoutria japonica, Persicaria perfoliata,Gentiana scabra, Houttuynia cordata, Rubia cordifolia, Prunellavulgaris, Hedyotis diffusa, Sophora flavescens, Dittany Bark.

Section 51945-4

Section 55105-1

External analgesic

Antiseptic

Section 55106-9

Camphor(2%)-----External analgesic

Menthol(2%)---External analgesic

Isopropyl Alcohol(75%)----------- Antiseptic

Section 60561-8

Store at 15°C-30°C(59°F-86°F)*Avoid sunlight and heat.

Tighten cap when not in use .

Use within 2 years of manufacture.

OTC drug. Not a substitute for medical care


Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves itching and discomfort from insect bites orminor skin irritations ,Provides mild antibacterial effect for skin

Dosage and Administration (34068-7)

Adults and children 2 years and older: Apply 3 to 4 times daily to the affected area.

Children under 2 years: Ask a doctor.

Warnings and Precautions (34071-1)

For external use only

Flammable: Keep away from heat or flameAvoid contact with eyes .

Stop use and ask a doctor if rash, irritationor symptoms worsen

Keep out of reach of children.

lf swallowedget medical help or contact a Poison Control Center right away

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Sophora tonkinensis, Pseudolaric Bark,Cogongrass RhizomeLobelia chinensis, Reynoutria japonica, Persicaria perfoliata,Gentiana scabra, Houttuynia cordata, Rubia cordifolia, Prunellavulgaris, Hedyotis diffusa, Sophora flavescens, Dittany Bark.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

External analgesic

Antiseptic

Section 55106-9 (55106-9)

Camphor(2%)-----External analgesic

Menthol(2%)---External analgesic

Isopropyl Alcohol(75%)----------- Antiseptic

Section 60561-8 (60561-8)

Store at 15°C-30°C(59°F-86°F)*Avoid sunlight and heat.

Tighten cap when not in use .

Use within 2 years of manufacture.

OTC drug. Not a substitute for medical care


Advanced Ingredient Data


Raw Label Data

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