SPL v5
SPL
SPL Set ID 5d35133e-3e49-4f51-a6e2-358265f57ccd
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 2014-04-08

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 arthritis, strains, bruises and sprains

Do Not

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

Section 42229-5

Flex24™ Performance Patch

Quick Relief for the Pain Of

Arthritis • Strains • Cramps • Bruises

Section 51945-4

Flex24™ Performance Patch

24/7 Topical Analgesic

Improve Performance

Reduce Pain

7 Large Patches

Lasts Up to 24 Hours

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 backing from patch and discard

• Apply one patch to affected area

•Patch should be comfortable but not tight

• Repeat if necessary but no more than 3 per day

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 54641-006-01

Made in China

Patch size 8 cm x 13 cm

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/performancepatch

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

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

Pregnancy Or Breast Feeding

ask healthcare professional about use

Keep Out of Reach of Children

If swallowed, get medical help or contact the 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

Section 42229-5 (42229-5)

Flex24™ Performance Patch

Quick Relief for the Pain Of

Arthritis • Strains • Cramps • Bruises

Section 51945-4 (51945-4)

Flex24™ Performance Patch

24/7 Topical Analgesic

Improve Performance

Reduce Pain

7 Large Patches

Lasts Up to 24 Hours

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 backing from patch and discard

• Apply one patch to affected area

•Patch should be comfortable but not tight

• Repeat if necessary but no more than 3 per day

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 54641-006-01

Made in China

Patch size 8 cm x 13 cm

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/performancepatch

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

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

Pregnancy Or Breast Feeding (Pregnancy 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 the Poison Control Center right away


Advanced Ingredient Data


Raw Label Data

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