Maxrevive ®

Maxrevive ®
SPL v2
SPL
SPL Set ID ce4a0aca-ef70-3a05-e053-2a95a90ae99e
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
Fd&c Blue No. 2 Zinc Oxide Yellow Ob Clematis Chinensis Root Momordica Cochinchinensis Seed Ricinus Communis Seed Myrrh Frankincense Sesame Oil Yellow Wax Pinus Massoniana Resin

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 50566-9

■ 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.

Section 50567-7

■ 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

Section 50570-1

Do not useotherwise than as directed.

Section 51727-6

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

Section 53413-1

Call:1-800-617-2021

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

Section 60561-8

■ Store unused patch in the pouch

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

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.

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 products ■ if allergic to aspirin or salicylates ■ if allergic to any ingredients of this product

Package Label

Directions (continued)

■ Wet patch with warm water before removing from skin.

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


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 50566-9 (50566-9)

■ 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.

Section 50567-7 (50567-7)

■ 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

Section 50570-1 (50570-1)

Do not useotherwise than as directed.

Section 51727-6 (51727-6)

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

Section 53413-1 (53413-1)

Call:1-800-617-2021

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

Section 60561-8 (60561-8)

■ Store unused patch in the pouch

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

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.

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 products ■ if allergic to aspirin or salicylates ■ if allergic to any ingredients of this product

Package Label

Directions (continued)

■ Wet patch with warm water before removing from skin.

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


Advanced Ingredient Data


Raw Label Data

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