Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 7dce5bb7-f4b3-4ce3-a456-f2d6e3b33e44
Route
TOPICAL
Published
Effective Date 2019-11-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (4 g)
Inactive Ingredients
Camphor Oil Angelica Sinensis Root Dragon's Blood Eucalyptus Oil Angelica Dahurica Root Frankincense Mentha Arvensis Whole Myrrh Citronella Oil Peppermint Oil Pinus Massoniana Resin Salvia Officinalis Root Safflower Ligusticum Sinense Subsp. Chuanxiong Whole Camellia Oleifera Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2004-03-29

Description

Active ingredients Camphor 4%


Medication Information

Warnings and Precautions

Warnings

For external use only

Allergy alert: Discontinue if irritation or rash appears. Prolonged or frequent skin contact may cause allergic reactions in some individuals.

Indications and Usage

Uses

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

simple backache, arthritis, strains, bruises, sprai

Dosage and Administration

Directions

Adults and children 2 years of age and older: Apply a few drops to the affected area and rub gently not more than 3 to 4 times daily.

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

Description

Active ingredients Camphor 4%

Section 44425-7

Other information

keep container tightly closed

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

Section 50565-1

Keep out of reach of children to avoid accidental poisoning.

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

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

Section 51727-6

Inactive ingredients

Camphor Oil, Dong-Quai root, Dragon’s Blood resin, Eucalyptus Oil, Fragrant Angelica Root, Frankincense gum resin, Field Mint herb, Myrrh gum resin, Oil of Citronella, Peppermint Oil, Pine resin, Red-Rooted Sage root, Safflower flower, Sichuan Lovage rhizome, Tea Oil

Section 51945-4

WONG LOP KONG MEDICATED OIL, External Analgesic, NDC 54188–003-01, 1 fl oz (30 mL)

Section 53413-1

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

Section 55105-1

Purpose

External analgesic

Section 55106-9

Active ingredients

Camphor 4%


Structured Label Content

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, sprai

Dosage and Administration (34068-7)

Directions

Adults and children 2 years of age and older: Apply a few drops to the affected area and rub gently not more than 3 to 4 times daily.

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

Warnings and Precautions (34071-1)

Warnings

For external use only

Allergy alert: Discontinue if irritation or rash appears. Prolonged or frequent skin contact may cause allergic reactions in some individuals.

Section 44425-7 (44425-7)

Other information

keep container tightly closed

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

Section 50565-1 (50565-1)

Keep out of reach of children to avoid accidental poisoning.

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

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

Section 51727-6 (51727-6)

Inactive ingredients

Camphor Oil, Dong-Quai root, Dragon’s Blood resin, Eucalyptus Oil, Fragrant Angelica Root, Frankincense gum resin, Field Mint herb, Myrrh gum resin, Oil of Citronella, Peppermint Oil, Pine resin, Red-Rooted Sage root, Safflower flower, Sichuan Lovage rhizome, Tea Oil

Section 51945-4 (51945-4)

WONG LOP KONG MEDICATED OIL, External Analgesic, NDC 54188–003-01, 1 fl oz (30 mL)

Section 53413-1 (53413-1)

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

Section 55105-1 (55105-1)

Purpose

External analgesic

Section 55106-9 (55106-9)

Active ingredients

Camphor 4%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)