SPL v2
SPL
SPL Set ID fa2951ae-a38a-4233-bd58-e1bf702a3e5c
Route
TOPICAL
Published
Effective Date 2017-01-21
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 Gardenia Jasminoides Fruit Angelica Sinensis Root Cotton Fiber Eucalyptus Oil Alcohol Forsythia Suspensa Fruit Drynaria Fortunei Root Frankincense Aconitum Kusnezoffii Root Lavender Oil Ginger Myrrh Peppermint Oil Pinellia Ternata Root Paeonia Obovata Root Rehmannia Elata Root Rhubarb Safflower Eleutherococcus Nodiflorus Root Bark Tangerine Peel Paeonia Suffruticosa Root Bark Turmeric Methyl Salicylate Paeonia Lactiflora Root

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-01-16

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

■ Bandage tightly

Section 42229-5

Larasan Pharmaceutical Corp.

1287 E. Newport Center Drive, Suite 206

Deerfield Beach, FL 33442

Section 51945-4

20170117Flex24PerfTape.jpg

Caution

■ Discontinue use if excessive irritation of the skin develops

■ Avoid contact with 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

■ Peel desired length of tape and cut with serrated edge.

■ Discard plastic backing from tape                                     ■ Repeat as necessary, but no more than 3 per day

■ Apply tape to affected area.                                             ■ Tape should be comfortably tight

■ Children under 12, consult a doctor before use

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.Flex24.com/performancetape

Inactive Ingredients

Angelica Dahurica, Cape Jasmine Fruit, Chinese Angelica, Cotton, Eucalyptus Oil, Ethyl Alcohol, Forsythia Seed Pod,

Fortune’s Drynaria Rhizome, Frankincense, Kusnezoff Monkshood root, Lavender Oil, Manchurian Wild Ginger, Myrrh,

Paper roll, Peppermint Oil, Pinellia Tuber, Red Peony Root, Rehmannia Root (raw), Rhubarb, Safflower, Slenderstyle

Acanthopanax Bark, Tangerine Peel, Tree Peony Bark, Turmeric, Weeping Wintergreen Oil, White Peony Root,

Zanthoxylum Nitidum, Zedoary.

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

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

■ Bandage tightly

Section 42229-5 (42229-5)

Larasan Pharmaceutical Corp.

1287 E. Newport Center Drive, Suite 206

Deerfield Beach, FL 33442

Section 51945-4 (51945-4)

20170117Flex24PerfTape.jpg

Caution

■ Discontinue use if excessive irritation of the skin develops

■ Avoid contact with 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

■ Peel desired length of tape and cut with serrated edge.

■ Discard plastic backing from tape                                     ■ Repeat as necessary, but no more than 3 per day

■ Apply tape to affected area.                                             ■ Tape should be comfortably tight

■ Children under 12, consult a doctor before use

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.Flex24.com/performancetape

Inactive Ingredients

Angelica Dahurica, Cape Jasmine Fruit, Chinese Angelica, Cotton, Eucalyptus Oil, Ethyl Alcohol, Forsythia Seed Pod,

Fortune’s Drynaria Rhizome, Frankincense, Kusnezoff Monkshood root, Lavender Oil, Manchurian Wild Ginger, Myrrh,

Paper roll, Peppermint Oil, Pinellia Tuber, Red Peony Root, Rehmannia Root (raw), Rhubarb, Safflower, Slenderstyle

Acanthopanax Bark, Tangerine Peel, Tree Peony Bark, Turmeric, Weeping Wintergreen Oil, White Peony Root,

Zanthoxylum Nitidum, Zedoary.

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

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


Advanced Ingredient Data


Raw Label Data

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