SPL v6
SPL
SPL Set ID 5a92a956-c001-3d14-e053-2a91aa0af839
Route
TOPICAL
Published
Effective Date 2017-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (2 g)
Inactive Ingredients
Arnica Montana Ginkgo Biloba Leaf Oil Ethylhexylglycerin Water Alcohol Dimethicone 200 Sodium Polyacrylate (8000 Mw) Panax Ginseng Root Oil Thymus Vulgaris Leaf

Identifiers & Packaging

Pill Appearance
Shape: freeform Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-08-31
Description

Massage into painful area until thoroughly absorbed into skin Repeat as necessary but not more than 3 to 4 times per day

Medication Information

Warnings and Precautions

WARNING: For external use only

DO NOT USE: On wounds or damaged skin with a heating pad

ASK A DOCTOR BEFORE USE IF:

  • You have redness over the affected area
  • Conditions worsen or sypmtoms persist for more than 7 days
  • Symptons clear up and occur again within a few days
  • Excessive skin irritation occurs
  • You are pregnant or breast feeding
Indications and Usage

Instant relief for:

Arthritis

Backache

Bruises

Cramps

Sprains

Strains

WHEN USING THIS PRODUCT:

  • Avoid contact with eyes or mucous membranes
  • Do not bandage tightly
Dosage and Administration
  • Massage into painful area until thoroughly absorbed into skin
  • Repeat as necessary but not more than 3 to 4 times per day
Description

Massage into painful area until thoroughly absorbed into skin Repeat as necessary but not more than 3 to 4 times per day

Section 50565-1

KEEP OUT OF REACH OF CHILDREN: If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Aqua/distilled/deionized

Rectified Alcohol

Arnica water-soluble

Beneficial Herbal Extract

Perservative 9010

Section 51945-4

Ez Massager 2

Section 55105-1

Topical Analgesic

Section 55106-9

Menthol, 2%

Structured Label Content

Indications and Usage (34067-9)

Instant relief for:

Arthritis

Backache

Bruises

Cramps

Sprains

Strains

WHEN USING THIS PRODUCT:

  • Avoid contact with eyes or mucous membranes
  • Do not bandage tightly
Dosage and Administration (34068-7)
  • Massage into painful area until thoroughly absorbed into skin
  • Repeat as necessary but not more than 3 to 4 times per day
Warnings and Precautions (34071-1)

WARNING: For external use only

DO NOT USE: On wounds or damaged skin with a heating pad

ASK A DOCTOR BEFORE USE IF:

  • You have redness over the affected area
  • Conditions worsen or sypmtoms persist for more than 7 days
  • Symptons clear up and occur again within a few days
  • Excessive skin irritation occurs
  • You are pregnant or breast feeding
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 51727-6 (51727-6)

Aqua/distilled/deionized

Rectified Alcohol

Arnica water-soluble

Beneficial Herbal Extract

Perservative 9010

Section 51945-4 (51945-4)

Ez Massager 2

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Menthol, 2%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:38.792176 · Updated: 2026-03-14T22:55:16.609561