SPL v1
SPL
SPL Set ID 94f27aa1-903e-4323-9cd5-6cfc59f7a63a
Route
TOPICAL
Published
Effective Date 2019-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (natural) (7.79 g)
Inactive Ingredients
Aconitum Kusnezoffii Root Angelica Dahurica Root Angelica Sinensis Root Drynaria Fortunei Root Eleutherococcus Nodiflorus Root Bark Alcohol Eucalyptus Oil Forsythia Suspensa Fruit Frankincense Gardenia Jasminoides Fruit Lavender Oil Lemon Myrrh Paeonia Suffruticosa Root Bark Peppermint Oil Pinellia Ternata Root Paeonia Lactiflora Root Rehmannia Glutinosa Root Rhubarb Safflower Tangerine Peel Turmeric Methyl Salicylate Zanthoxylum Nitidum Root Zedoary

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-08-28

Description

Camphor, 7.79%

Purpose

Topical analgesic


Medication Information

Warnings and Precautions

​For external use only

Purpose

Topical analgesic

Description

Camphor, 7.79%

Uses

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

Do Not

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

Section 42229-5

FLEX24®

RECOVER NATURALLY

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 a Poison Control Center right away

Section 51945-4

ROLL-ON PEN

PAIN RELIEF

WORKS FOR ARTHRITIS

• ALL NATURAL

• FAST ACTING

• LONG LASTING

Topical Analgesic

0.61 fl. oz. (18 mL)

• Plant based medicine for pain relief

• Fast acting and long lasting

• Works for: aches, pains, & strains

FLEX24®

RECOVER NATURALLY

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.

Directions

Adults and children 2 years of age and older:

• Remove plastic top from device and put aside till after treatment

• Squeeze device if necessary and apply ointment to the affected area

• Repeat as necessary but no more than 3 treatments per day

Children under 2 years of age, consult a physician.

Active Ingredient

Camphor, 7.79%

Inactive Ingredients

Aconitum Kusnezoffii Root, Angelica Dahurica Root, Angelica Sinesis Root, Asarum Heterotropoides var. Drynaria Fortunei Root, Eleutherococcus Nodiflorus Root Bark, Ethyl Alcohol, Eucalyptus Oil, Frosythia Suspensa Fruit, Frankincense, Gardenia Jasminoides Fruit, Lavender Oil, Lemon, Myrrh, Paeonia Suffruticosa Root Bark, Peppermint Oil, Pinellia Ternata Root, Red Paeonia Lactiflora Root, Rehmannia Glutinosa Root (Raw), Rhubarb, Safflower, Tangerine Peel, Turmeric, White Paeonia Lactiflora Root, Wintergreen Oil, Zanthoxylum Nitidum Root, Zeodary

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.


Structured Label Content

Uses

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

Do Not (Do not)

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

Warnings and Precautions (34071-1)

​For external use only

Section 42229-5 (42229-5)

FLEX24®

RECOVER NATURALLY

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 a Poison Control Center right away

Section 51945-4 (51945-4)

ROLL-ON PEN

PAIN RELIEF

WORKS FOR ARTHRITIS

• ALL NATURAL

• FAST ACTING

• LONG LASTING

Topical Analgesic

0.61 fl. oz. (18 mL)

• Plant based medicine for pain relief

• Fast acting and long lasting

• Works for: aches, pains, & strains

FLEX24®

RECOVER NATURALLY

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

Directions

Adults and children 2 years of age and older:

• Remove plastic top from device and put aside till after treatment

• Squeeze device if necessary and apply ointment to the affected area

• Repeat as necessary but no more than 3 treatments per day

Children under 2 years of age, consult a physician.

Active Ingredient

Camphor, 7.79%

Inactive Ingredients

Aconitum Kusnezoffii Root, Angelica Dahurica Root, Angelica Sinesis Root, Asarum Heterotropoides var. Drynaria Fortunei Root, Eleutherococcus Nodiflorus Root Bark, Ethyl Alcohol, Eucalyptus Oil, Frosythia Suspensa Fruit, Frankincense, Gardenia Jasminoides Fruit, Lavender Oil, Lemon, Myrrh, Paeonia Suffruticosa Root Bark, Peppermint Oil, Pinellia Ternata Root, Red Paeonia Lactiflora Root, Rehmannia Glutinosa Root (Raw), Rhubarb, Safflower, Tangerine Peel, Turmeric, White Paeonia Lactiflora Root, Wintergreen Oil, Zanthoxylum Nitidum Root, Zeodary

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.


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