Maxrevive ®

Maxrevive ®
SPL v2
SPL
SPL Set ID ce48f4fe-912e-4bd2-e053-2995a90a6162
Route
TOPICAL
Published
Effective Date 2021-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (0.04 g) Salicylic Acid (0.01 g)
Inactive Ingredients
Momordica Cochinchinensis Seed Clematis Chinensis Root Yellow Wax Sesame Oil Frankincense Yellow Ob Ricinus Communis Seed Myrrh Pinus Massoniana Resin Fd&c Blue No. 2 Zinc Oxide

Identifiers & Packaging

Pill Appearance
Shape: rectangle Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-10-11

Description

Backache, Arthritis, Strains, Bruises, Sprains


Medication Information

Description

Backache, Arthritis, Strains, Bruises, Sprains

Uses

For the temporary relief of minor aches and pains of

muscles and joints associated with: ■ arthritis ■ strains ■ bruises ■ sprains ■ simple backache

Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50565-1

Keep out of reach of childrento avoid accidental poisoning

Section 50570-1

Do not use otherwise than as directed.

Section 53414-9

If pregnant. ask a health professional before use.

Section 55105-1

Backache, Arthritis, Strains, Bruises, Sprains

Section 55106-9
Active Ingredients Purpose
Menthol 4% External Analgesic
Methyl Salicylate 1% External Analgesic

Warnings

For external use only

Directions

■ Adults and children 12 years of age and older: clean and dry affected area. Remove plaster from the protective layer, apply to the affected area, rub the area with your hand to secure the patch.

■ Plaster will remain effective for 8 hours.

■ Avoid using the same patch on the same area for more than 2 days.

■ Do not apply to area with excessive hair. Adhesive plaster may hurt skin upon removal.

■ Wet patch with warm water before removing from skin.

■ Children under 12 years of age: Do not use or consult a doctor.

Do Not Use

■ on wounds ■ irritated or damaged skin ■ sensitive skin ■ with a heating pad ■ if pregnant ■ with, or as the same time as, other external analgesic P.roducts ■ if allergic to aspirin or salicylates ■ 1f allergic to any ingredients of this product

Other Information

■ Store unused patch in the pouch

■ Store at room temperature, 20 to 25°C(68 to 77°F)

Inactive Ingredients

Chinese Clematidis Root & Rhizome,Yellow wax, Momordica cochinchinensis seeds, Castor Seeds, Myrrh, Frankincense, Sesame Oil, Resin, FD&C Blue No_ 2, FD&C Yellow No. 4, Zinc Oxide

Questions Or Comments

Call: 1-800-617-2021

When Using This Product

■ avoid contact with the eyes

■ do not bandage tightly

■ do not apply to wounds or damaged skin

■ do not use more than 3 plasters a day

■ do not use 1 hour before or after bathing

Stop Use and Ask A Doctor If

■ condition worsens

■ symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days

■ excessive irritation of the skin develops

■ rashes, itching or redness are present

■ side effects occur.

Package Label Principal Display Panel


Structured Label Content

Uses

For the temporary relief of minor aches and pains of

muscles and joints associated with: ■ arthritis ■ strains ■ bruises ■ sprains ■ simple backache

Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep out of reach of childrento avoid accidental poisoning

Section 50570-1 (50570-1)

Do not use otherwise than as directed.

Section 53414-9 (53414-9)

If pregnant. ask a health professional before use.

Section 55105-1 (55105-1)

Backache, Arthritis, Strains, Bruises, Sprains

Section 55106-9 (55106-9)
Active Ingredients Purpose
Menthol 4% External Analgesic
Methyl Salicylate 1% External Analgesic

Warnings

For external use only

Directions

■ Adults and children 12 years of age and older: clean and dry affected area. Remove plaster from the protective layer, apply to the affected area, rub the area with your hand to secure the patch.

■ Plaster will remain effective for 8 hours.

■ Avoid using the same patch on the same area for more than 2 days.

■ Do not apply to area with excessive hair. Adhesive plaster may hurt skin upon removal.

■ Wet patch with warm water before removing from skin.

■ Children under 12 years of age: Do not use or consult a doctor.

Do Not Use (Do not use)

■ on wounds ■ irritated or damaged skin ■ sensitive skin ■ with a heating pad ■ if pregnant ■ with, or as the same time as, other external analgesic P.roducts ■ if allergic to aspirin or salicylates ■ 1f allergic to any ingredients of this product

Other Information

■ Store unused patch in the pouch

■ Store at room temperature, 20 to 25°C(68 to 77°F)

Inactive Ingredients

Chinese Clematidis Root & Rhizome,Yellow wax, Momordica cochinchinensis seeds, Castor Seeds, Myrrh, Frankincense, Sesame Oil, Resin, FD&C Blue No_ 2, FD&C Yellow No. 4, Zinc Oxide

Questions Or Comments (Questions or Comments)

Call: 1-800-617-2021

When Using This Product (When using this product)

■ avoid contact with the eyes

■ do not bandage tightly

■ do not apply to wounds or damaged skin

■ do not use more than 3 plasters a day

■ do not use 1 hour before or after bathing

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ condition worsens

■ symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days

■ excessive irritation of the skin develops

■ rashes, itching or redness are present

■ side effects occur.

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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