Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 671c57f0-3c6f-4416-bc81-f6930fef327b
Route
TOPICAL
Published
Effective Date 2023-10-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (128.04 mg) Capsaicin (2.88 mg) Salicylic Acid (168.03 mg)
Inactive Ingredients
Peppermint Oil Petrolatum Lanolin Rosin Zinc Oxide Natural Latex Rubber

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-08-07 Until 2026-10-31

Description

Active ingredients Camphor 11% Capsaicin 0.25% Methyl salicylate 14.24%


Medication Information

Warnings and Precautions

Warnings

For external use only

Allergy alert:This product contains natural rubber latex which may cause allergic reactions

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

adults and children 3 years of age and older: remove the attached film from the plaster. Apply to affected area not more than 3 to 4 times daily

children under 3 years of age: consult your physician

refer to the above warnings; use otherwise than as directed may be dangerous

Description

Active ingredients Camphor 11% Capsaicin 0.25% Methyl salicylate 14.24%

Section 44425-7

Other information

keep tightly closed

store at 15 to 30C (59 to 86F)

Section 50565-1

Keep out of reach of childrento avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor ifcondition 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

Section 50570-1

Do not use

on irritated or damaged skin

on wounds

otherwise than as directed

Section 51727-6

Inactive ingredients Peppermint oil, petrolatum, lanolin, rosin, and zinc oxide, on a natural latex rubber pad.

Section 51945-4

ARTHRITIS PAIN RELIEF PATCH

External Analgesic

NDC 61658-002-01

Camphor 11%, Capsaicin 0.25%, Methyl Salicylate 14.24%

6 Patches

Each Patch 7 x 10 cm (2.76 x 3.94 in)

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

External analgesic

External analgesic

Section 55106-9

Active ingredients

Camphor 11%

Capsaicin 0.25%

Methyl salicylate 14.24%


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

adults and children 3 years of age and older: remove the attached film from the plaster. Apply to affected area not more than 3 to 4 times daily

children under 3 years of age: consult your physician

refer to the above warnings; use otherwise than as directed may be dangerous

Warnings and Precautions (34071-1)

Warnings

For external use only

Allergy alert:This product contains natural rubber latex which may cause allergic reactions

Section 44425-7 (44425-7)

Other information

keep tightly closed

store at 15 to 30C (59 to 86F)

Section 50565-1 (50565-1)

Keep out of reach of childrento avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor ifcondition 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

Section 50570-1 (50570-1)

Do not use

on irritated or damaged skin

on wounds

otherwise than as directed

Section 51727-6 (51727-6)

Inactive ingredients Peppermint oil, petrolatum, lanolin, rosin, and zinc oxide, on a natural latex rubber pad.

Section 51945-4 (51945-4)

ARTHRITIS PAIN RELIEF PATCH

External Analgesic

NDC 61658-002-01

Camphor 11%, Capsaicin 0.25%, Methyl Salicylate 14.24%

6 Patches

Each Patch 7 x 10 cm (2.76 x 3.94 in)

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

External analgesic

External analgesic

Section 55106-9 (55106-9)

Active ingredients

Camphor 11%

Capsaicin 0.25%

Methyl salicylate 14.24%


Advanced Ingredient Data


Raw Label Data

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