SPL v1
SPL
SPL Set ID ecc419e9-a89d-4c5d-988f-3d646779d959
Route
TOPICAL
Published
Effective Date 2019-09-15
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 2019-09-16

Description

Camphor, 3% Menthol, 2.52%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Camphor, 3% Menthol, 2.52%

Uses

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

Do Not
  • Apply to open wounds, or damaged, broken, or irritated skin
Section 42229-5

RELIEF FOR:

WRIST PAIN

ELBOW STRAIN

SHOULDER PAIN

BACK PAIN

CALF STRAIN

ANKLE SPRAIN

HAMSTRING SPRAIN

Dist: Flex24, Inc.

4020 Galt Ocean Mile, Ste. 1607

Ft. Lauderdale, FL 33308

Tel: 844.4.FLEX24

Formulated in USA

Made in China

Section 50565-1

Keep out of reach of children.  If swallowed, get medical help or contact the Poison Control Center right away.

Section 51945-4

FLEX24®

RECOVER NATURALLY

HAS NATURAL MEDICINE FOR PAIN RELIEF

LONG LASTING FOR INCREASED ACTIVITY

WATERPROOF, FLEXIBLE, STAYS ON ALL-DAY

TOPICAL ANALGESIC

contents: 1 tape roll, 2 in. x 16.4 ft. (5 cm x 5 m)

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 tape from box and cut to desired length
  • Apply cut tape to affected area
  • Repeat if necessary but no more than 3 per day
  • Tape should be comfortable but not tight
  • Sensitive skin - remove tape under water

Children under 12 years of age, consult a doctor

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 Monkshoot Root (raw), Lemon, Ligusticum Sinese Subsp. Chuansiong Root, Mineral Oil, Musk, Petrolatum, Radix Aconiti, 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 persis for more than 7 days or clear up and occur again within a few days


Structured Label Content

Uses

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

Do Not (Do not)
  • Apply to open wounds, or damaged, broken, or irritated skin
Section 42229-5 (42229-5)

RELIEF FOR:

WRIST PAIN

ELBOW STRAIN

SHOULDER PAIN

BACK PAIN

CALF STRAIN

ANKLE SPRAIN

HAMSTRING SPRAIN

Dist: Flex24, Inc.

4020 Galt Ocean Mile, Ste. 1607

Ft. Lauderdale, FL 33308

Tel: 844.4.FLEX24

Formulated in USA

Made in China

Section 50565-1 (50565-1)

Keep out of reach of children.  If swallowed, get medical help or contact the Poison Control Center right away.

Section 51945-4 (51945-4)

FLEX24®

RECOVER NATURALLY

HAS NATURAL MEDICINE FOR PAIN RELIEF

LONG LASTING FOR INCREASED ACTIVITY

WATERPROOF, FLEXIBLE, STAYS ON ALL-DAY

TOPICAL ANALGESIC

contents: 1 tape roll, 2 in. x 16.4 ft. (5 cm x 5 m)

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 tape from box and cut to desired length
  • Apply cut tape to affected area
  • Repeat if necessary but no more than 3 per day
  • Tape should be comfortable but not tight
  • Sensitive skin - remove tape under water

Children under 12 years of age, consult a doctor

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 Monkshoot Root (raw), Lemon, Ligusticum Sinese Subsp. Chuansiong Root, Mineral Oil, Musk, Petrolatum, Radix Aconiti, 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 persis for more than 7 days or clear up and occur again within a few days


Advanced Ingredient Data


Raw Label Data

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