SPL v4
SPL
SPL Set ID 83e34c16-d505-4d6b-af22-cf21ed6da109
Route
TOPICAL
Published
Effective Date 2019-12-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (natural) (7.79 g)
Inactive Ingredients
Angelica Dahurica Root Aconitum Kusnezoffii Root Angelica Sinensis Root Asarum Heterotropoides Var. Mandshuricum Root Drynaria Fortunei Root Eleutherococcus Nodiflorus Root Bark Alcohol Eucalyptus Oil Forsythia Suspensa Fruit Frankincense Gardenia Jasminoides Fruit Lavender Oil Lemon Myrrh Paeonia Suffruticosa Root Bark Peppermint Oil Pinellia Ternata Root Paeonia Lactiflora Root Rehmannia Glutinosa Root Rhubarb Safflower Tangerine Peel Turmeric Methyl Salicylate Zanthoxylum Nitidum Root Zedoary

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-04-08

Description

Camphor, 7.79%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Camphor, 7.79%

Uses

For temporary relief of minor aches and pains of muscle and joints associated with simple arthritis, strains, bruises and sprains

Do Not

apply to open wounds, or damaged, broken, or irritated skin

Caution
  • Discontinue use if excessive irritation of the skin develops
  • Avoid contact with the eyes and mucous membranes
  • Arthritis: If pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age consult a physician immediately
Warnings

For external use only

Directions

Adults and children over the age of 12:

  • Remove plastic top from device and put aside till after treatment
  • Apply ointment to affected area
  • Repeat if necessary but no more than 3 treatments a day.

Children under 12, consult a doctor before use.

Distributed By:

Larasan Pharmaceutical Corporation

401 East Las Olas Blvd., Suite 1400

Ft. Lauderdale, FL 33301

Tel. 1-855-LARASAN

NDC 54641-004-02

Made in China

Active Ingredient

Camphor, 7.79%

Other Information

Keep sealed in a dry environment at no more than 85°F/29°C and avoid any direct sun exposure

Questions/comments?

www.larasan.com/performancepen

Inactive Ingredients

Aconitum kusnezoffii root, Angelica dahurica root, Angelica sinesis root, Asarum heterotropoides var. mandshuricum root, Drynaria fortunei root, Eleutherococcus nodiflorus root bark, Ethyl alcohol, Eucalyptus oil, Frosythia suspensa fruit, Frankincense, Gardenia jasminoides fruit, Lavender oil, Lemon, Myrrh, Paeonia suffruticosa root bark, Peppermint oil, Pinellia ternata root, Red paeonia lactiflora root, Rhemannia glutinosa root (raw), Rhubarb, Safflower, Tangerine peel, Turmeric, White paeonia lactiflora root, Wintergreen oil, Zanthoxylum nitidum root, Zeodary

Flex24™ Performance Pen

Topical Analgesic

Aches Pains Bruises Sprains

0.34 fl. oz. (10 mL)

Stop Use and Ask A Doctor

if condition worsens or if there is redness or irritation in the applied area or if symptoms persist for more than 7 days or clear up and occur again within a few days

Pregnant Or Breast Feeding

ask healthcare professional about use

Keep Out of Reach of Children

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


Structured Label Content

Uses

For temporary relief of minor aches and pains of muscle and joints associated with simple arthritis, strains, bruises and sprains

Do Not (Do not)

apply to open wounds, or damaged, broken, or irritated skin

Caution
  • Discontinue use if excessive irritation of the skin develops
  • Avoid contact with the eyes and mucous membranes
  • Arthritis: If pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age consult a physician immediately
Purpose

Topical analgesic

Warnings

For external use only

Directions

Adults and children over the age of 12:

  • Remove plastic top from device and put aside till after treatment
  • Apply ointment to affected area
  • Repeat if necessary but no more than 3 treatments a day.

Children under 12, consult a doctor before use.

Distributed By:

Larasan Pharmaceutical Corporation

401 East Las Olas Blvd., Suite 1400

Ft. Lauderdale, FL 33301

Tel. 1-855-LARASAN

NDC 54641-004-02

Made in China

Active Ingredient

Camphor, 7.79%

Other Information

Keep sealed in a dry environment at no more than 85°F/29°C and avoid any direct sun exposure

Questions/comments? (Questions/Comments?)

www.larasan.com/performancepen

Inactive Ingredients

Aconitum kusnezoffii root, Angelica dahurica root, Angelica sinesis root, Asarum heterotropoides var. mandshuricum root, Drynaria fortunei root, Eleutherococcus nodiflorus root bark, Ethyl alcohol, Eucalyptus oil, Frosythia suspensa fruit, Frankincense, Gardenia jasminoides fruit, Lavender oil, Lemon, Myrrh, Paeonia suffruticosa root bark, Peppermint oil, Pinellia ternata root, Red paeonia lactiflora root, Rhemannia glutinosa root (raw), Rhubarb, Safflower, Tangerine peel, Turmeric, White paeonia lactiflora root, Wintergreen oil, Zanthoxylum nitidum root, Zeodary

Flex24™ Performance Pen

Topical Analgesic

Aches Pains Bruises Sprains

0.34 fl. oz. (10 mL)

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if condition worsens or if there is redness or irritation in the applied area or if symptoms persist for more than 7 days or clear up and occur again within a few days

Pregnant Or Breast Feeding (Pregnant or breast feeding)

ask healthcare professional about use

Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)