Owell Naturals Pain Relief Cream

Owell Naturals Pain Relief Cream
SPL v1
SPL
SPL Set ID 231e60ab-7044-3911-e063-6394a90a685e
Route
TOPICAL
Published
Effective Date 2024-09-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (8 g)
Inactive Ingredients
Sunflower Seed Oil Glycereth-8 Esters Peg-8 Beeswax Caprylyl Glycol Abies Sibirica Leaf Oil Water Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Eucalyptus Globulus Leaf Cinnamomum Camphora Whole Sodium Chloride Aloe Vera Leaf Methyl Salicylate Safflower Oil Chlorphenesin Hydrogenated Castor Oil Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-20

Description

Menthol 8%


Medication Information

Warnings and Precautions

Warnings

For External Use Only.

Allergy Alert: If prone to allergic reaction from aspirin or salicylate, consult your doctor before using.

Do Not Use

■ on wounds or damaged skin ■ with a heating pad

■ on a child under 12 years of age with arthritis-like conditions

Ask a doctor before use if you have redness over the affected area.

When Using This Product ■ avoid contact with eyes or other sensitive areas ■ do not bandage tightly

Stop use and ask a doctor if

■ condition worsens or symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days

■ excessive skin irritation occurs

Keep out of reach of children to avoid accidental ingestion. If swal- lowed, get medical help or contact

a Poison Control Center immediately.

Indications and Usage

Arthritis Pain, Sore Joints and Muscles, Sore Throat, Sinus Trouble, Restless Leg Syndrome

Dosage and Administration

Directions ■ use only as directed

■ adults and children 12 years of age and older: apply to affected area

■ children under 12 years of age: ask a doctor

Description

Menthol 8%

Section 50565-1

Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 51727-6

Inactive ingredients Water, Carthamus tinctorius (Hybrid Safflower) Seed Oil, Helianthus annuus (Sunflower) Seed Oil, Cetyl PEG/PPG-10/1 Dimethicone, Aloe barbadensis (Aloe Vera) Leaf Juice, Beeswax, Hydro- genated Castor Oil, Caprylyl Glycol, Phenoxyethanol, Eucalyptus globulus Leaf Oil, Chlorphenesin, Cinnamomum camphora Bark Oil, Abies sibirica Needle Oil, Methyl Salicylate, Sodium Chloride

Section 51945-4

Section 55105-1

Topical Analgesic

Section 55106-9

Menthol 8%


Structured Label Content

Indications and Usage (34067-9)

Arthritis Pain, Sore Joints and Muscles, Sore Throat, Sinus Trouble, Restless Leg Syndrome

Dosage and Administration (34068-7)

Directions ■ use only as directed

■ adults and children 12 years of age and older: apply to affected area

■ children under 12 years of age: ask a doctor

Warnings and Precautions (34071-1)

Warnings

For External Use Only.

Allergy Alert: If prone to allergic reaction from aspirin or salicylate, consult your doctor before using.

Do Not Use

■ on wounds or damaged skin ■ with a heating pad

■ on a child under 12 years of age with arthritis-like conditions

Ask a doctor before use if you have redness over the affected area.

When Using This Product ■ avoid contact with eyes or other sensitive areas ■ do not bandage tightly

Stop use and ask a doctor if

■ condition worsens or symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days

■ excessive skin irritation occurs

Keep out of reach of children to avoid accidental ingestion. If swal- lowed, get medical help or contact

a Poison Control Center immediately.

Section 50565-1 (50565-1)

Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 51727-6 (51727-6)

Inactive ingredients Water, Carthamus tinctorius (Hybrid Safflower) Seed Oil, Helianthus annuus (Sunflower) Seed Oil, Cetyl PEG/PPG-10/1 Dimethicone, Aloe barbadensis (Aloe Vera) Leaf Juice, Beeswax, Hydro- genated Castor Oil, Caprylyl Glycol, Phenoxyethanol, Eucalyptus globulus Leaf Oil, Chlorphenesin, Cinnamomum camphora Bark Oil, Abies sibirica Needle Oil, Methyl Salicylate, Sodium Chloride

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Menthol 8%


Advanced Ingredient Data


Raw Label Data

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