Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 3adfac16-ea7b-47df-89f5-91bbd09c4fe1
Route
TOPICAL
Published
Effective Date 2018-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (248 mg) Menthol (100 mg)
Inactive Ingredients
Aluminum Hydroxide Capsicum Cinnamon Oil Angelica Sinensis Root Erycibe Obtusifolia Stem Angelica Dahurica Root Frankincense Zingiber Officinale Whole Glycerin Piper Kadsura Stem Kaolin Polyacrylic Acid (800000 Mw) Panax Notoginseng Root Huperzia Serrata Titanium Dioxide Turmeric Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-06-26 Until 2028-10-31

Description

Active ingredients Camphor 3.1% Menthol 1.25%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

For the temporary relief of minor aches and pains of muscles and joints due to:

simple backache

arthritis

strains

bruises

sprains

Dosage and Administration

Directions

Clean the affected area. Remove the paper film from the patch, and place the patch on the affected area, so that the direction of stretch is consistent with joint action.

adults and children 8 years of age and older: apply to affected area not more than 3 to 4 times daily. Do not use this product for longer than 8 hours in one day.

children under 8 years of age: do not use, consult your physician

Description

Active ingredients Camphor 3.1% Menthol 1.25%

Section 44425-7

Other information

keep tightly sealed

store at 8 to 30 C (46 to 86 F), away from sunlight

Section 50565-1

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

Section 50566-9

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

nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs

when using for pain of arthritis:

     pain persists for more than 10 days

     redness is present

     in conditions affecting children under 12 years of age

Section 50567-7

When using this product

avoid contact with the eyes or mucous membranes

do not bandage tightly

supervise use by children

use caution if prone to allergies

check carefully for hypersensitivity (skin reactions)

avoid placing on extremely hairy areas of skin to avoid irritation upon removing the patch

Section 50568-5

Ask a doctor or pharmacist before use if you are

using other medications

if pregnant or nursing

Section 50570-1

Do not use

on wounds

on large parts of the body for extended periods of time

on irritated or damaged skin

if properties of this product change

Section 51727-6

Inactive ingredients

aluminum hydroxide, capsicum, cinnamon oil, dong-quai root, erycibe (Erycibe obtusifolia Benth.) stem, fragrant angelica root, frankincense oleo-gum-resin, ginger rhizome, glycerin, kadsura pepper [Piper kadsura (Choisy) Ohwi] stem, kaolin, polyacrylic acid, san-qi ginseng root, stephania (Stephania sinica Diels.) root, titanium dioxide, turmeric rhizome, and water on a fabric backing covered with protective paper film.

Section 51945-4

Gutong Tiegao Hydrogel Pain Relieving Patch

NDC 68007-301-01

6 Patches

Each Patch 2.75 in x 4 in (7 cm x 10 cm)

2 Patches Per Pouch

Section 53413-1

Questions or comments? (888) 221-3496 M-F 9 am to 5 pm

you may also report serious side effects to this phone number

Section 55105-1

Purpose

External analgesic

Section 55106-9

Active ingredients

Camphor 3.1%

Menthol 1.25%


Structured Label Content

Indications and Usage (34067-9)

Uses

For the temporary relief of minor aches and pains of muscles and joints due to:

simple backache

arthritis

strains

bruises

sprains

Dosage and Administration (34068-7)

Directions

Clean the affected area. Remove the paper film from the patch, and place the patch on the affected area, so that the direction of stretch is consistent with joint action.

adults and children 8 years of age and older: apply to affected area not more than 3 to 4 times daily. Do not use this product for longer than 8 hours in one day.

children under 8 years of age: do not use, consult your physician

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

keep tightly sealed

store at 8 to 30 C (46 to 86 F), away from sunlight

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 50566-9 (50566-9)

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

nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs

when using for pain of arthritis:

     pain persists for more than 10 days

     redness is present

     in conditions affecting children under 12 years of age

Section 50567-7 (50567-7)

When using this product

avoid contact with the eyes or mucous membranes

do not bandage tightly

supervise use by children

use caution if prone to allergies

check carefully for hypersensitivity (skin reactions)

avoid placing on extremely hairy areas of skin to avoid irritation upon removing the patch

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

using other medications

if pregnant or nursing

Section 50570-1 (50570-1)

Do not use

on wounds

on large parts of the body for extended periods of time

on irritated or damaged skin

if properties of this product change

Section 51727-6 (51727-6)

Inactive ingredients

aluminum hydroxide, capsicum, cinnamon oil, dong-quai root, erycibe (Erycibe obtusifolia Benth.) stem, fragrant angelica root, frankincense oleo-gum-resin, ginger rhizome, glycerin, kadsura pepper [Piper kadsura (Choisy) Ohwi] stem, kaolin, polyacrylic acid, san-qi ginseng root, stephania (Stephania sinica Diels.) root, titanium dioxide, turmeric rhizome, and water on a fabric backing covered with protective paper film.

Section 51945-4 (51945-4)

Gutong Tiegao Hydrogel Pain Relieving Patch

NDC 68007-301-01

6 Patches

Each Patch 2.75 in x 4 in (7 cm x 10 cm)

2 Patches Per Pouch

Section 53413-1 (53413-1)

Questions or comments? (888) 221-3496 M-F 9 am to 5 pm

you may also report serious side effects to this phone number

Section 55105-1 (55105-1)

Purpose

External analgesic

Section 55106-9 (55106-9)

Active ingredients

Camphor 3.1%

Menthol 1.25%


Advanced Ingredient Data


Raw Label Data

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