SPL v2
SPL
SPL Set ID 9068cd94-7c29-482a-b8b8-f66c2048b396
Route
TOPICAL
Published
Effective Date 2019-12-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (natural) (3 g) Menthol (2.52 g)
Inactive Ingredients
Angelica Dahurica Root Atractylodes Lancea Root Borneol Angelica Sinensis Root Chondroitin Sulfate (bovine) Ginger Kaempferia Galanga Root Aconitum Kusnezoffii Root Lemon Ligusticum Sinense Subsp. Chuanxiong Root Mineral Oil Moschus Berezovskii Musk Sac Resin Petrolatum Aconitum Napellus Root Rosin Star Anise Methyl Salicylate Zinc Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-09-12

Description

Camphor, 3% Menthol, 2.52%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Camphor, 3% Menthol, 2.52%

Uses

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

Do Not

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

Section 42229-5

Flex24™ Pain Patch

Quick Relief for the Pain of

Arthritis • Strains • Cramps • Bruises

Section 51945-4

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 immedately
Warnings

​For external use only

Directions

Adults and children over the age of 12:

  • Remove plastic backing from patch and discard
  • Apply one patch to affected area
  • Repeat if necessary, but no more than 3 per day
  • Patch shold be comfortable but not tight

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 54641-005-01

Made in China

Other Information

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

Active Ingredients

Camphor, 3%

Menthol, 2.52%

Questions/comments?

www.larasan.com/painpatch

Inactive Ingredients

Angelica Dahurica Root, Atractylodes Lancea Root, Borneol, Chinese Angelica, Chondroitin Sulfate, Ginger, Kaempferia Galanga Root, Kusnezoff Monkshood Root (raw), Lemon, Ligusticum Sinense/Subsp. Chuanxiong Root, Mineral Oil, Musk, Petrolatum, Radix Aconiti, Rosin, Silicone, Star Anise, Wintergreen Oil, Zinc Oxide

Pregant Or Breast Feeding

ask a healthcare professional about use.

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.

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 backache, arthritis, strains, cramps, bruises, and sprains.

Do Not (Do not)

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

Section 42229-5 (42229-5)

Flex24™ Pain Patch

Quick Relief for the Pain of

Arthritis • Strains • Cramps • Bruises

Section 51945-4 (51945-4)

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 immedately
Purpose

Topical Analgesic

Warnings

​For external use only

Directions

Adults and children over the age of 12:

  • Remove plastic backing from patch and discard
  • Apply one patch to affected area
  • Repeat if necessary, but no more than 3 per day
  • Patch shold be comfortable but not tight

Children under 12: consult a doctor before use

Distributed By: (Distributed by:)

Larasan Pharmaceutical Corporation

401 East Las Olas Blvd., Suite 1400

Ft. Lauderdale, FL 33301

Tel. 1-855-LARASAN

NDC 54641-005-01

Made in China

Other Information

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

Active Ingredients

Camphor, 3%

Menthol, 2.52%

Questions/comments? (Questions/Comments?)

www.larasan.com/painpatch

Inactive Ingredients

Angelica Dahurica Root, Atractylodes Lancea Root, Borneol, Chinese Angelica, Chondroitin Sulfate, Ginger, Kaempferia Galanga Root, Kusnezoff Monkshood Root (raw), Lemon, Ligusticum Sinense/Subsp. Chuanxiong Root, Mineral Oil, Musk, Petrolatum, Radix Aconiti, Rosin, Silicone, Star Anise, Wintergreen Oil, Zinc Oxide

Pregant Or Breast Feeding (Pregant or breast feeding)

ask a healthcare professional about use.

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.

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

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