SPL v1
SPL
SPL Set ID 5668d4cb-c938-435c-81d9-a1bbf8c67f68
Route
TOPICAL
Published
Effective Date 2019-08-28
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 2019-08-28

Description

Camphor, 3% Menthol, 2.52%

Purpose

Topical Analgesic


Medication Information

Warnings and Precautions

For external use only

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.

Section 42229-5

Download the FLEX24 App

Dist: FLEX24, INC.

        4020 Galt Ocean Mile, Ste. 1607

        Ft. Lauderdale, FL 33308

       Tel: 844.4.FLEX24

Formulated in the USA

Section 43685-7

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
Section 50565-1

​Keep out of reach of children.​  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 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.

Section 50570-1

Do not

  • Apply to open wounds, or damaged, broken, or irritated skin
Section 51945-4

FLEX24.COM

FLEX24®

RECOVER NATURALLY

TOPICAL ANALGESIC PAIN PATCH

24 Hour Relief

7 Large Patches

Patch size 8 cm x 13 cm

All Natural

Long Lasting

Reduces Pain

Strong Natural Pain Relief

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 should be comfortable but not tight
  • Sensitive skin – Remove patch under water

Children under 12: consult a doctor before use

Active Ingredients

Camphor, 3%

Menthol, 2.52%

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


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.

Warnings and Precautions (34071-1)

For external use only

Section 42229-5 (42229-5)

Download the FLEX24 App

Dist: FLEX24, INC.

        4020 Galt Ocean Mile, Ste. 1607

        Ft. Lauderdale, FL 33308

       Tel: 844.4.FLEX24

Formulated in the USA

Section 43685-7 (43685-7)

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
Section 50565-1 (50565-1)

​Keep out of reach of children.​  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 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.

Section 50570-1 (50570-1)

Do not

  • Apply to open wounds, or damaged, broken, or irritated skin
Section 51945-4 (51945-4)

FLEX24.COM

FLEX24®

RECOVER NATURALLY

TOPICAL ANALGESIC PAIN PATCH

24 Hour Relief

7 Large Patches

Patch size 8 cm x 13 cm

All Natural

Long Lasting

Reduces Pain

Strong Natural Pain Relief

Purpose

Topical Analgesic

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 should be comfortable but not tight
  • Sensitive skin – Remove patch under water

Children under 12: consult a doctor before use

Active Ingredients

Camphor, 3%

Menthol, 2.52%

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)