SPL v9
SPL
SPL Set ID 6f5b9e08-c445-4fac-e053-2a91aa0aa737
Route
TOPICAL
Published
Effective Date 2018-11-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.5 g)
Inactive Ingredients
Jojoba Oil Polyglyceryl-3 Laurate Water Isopropyl Palmitate Coconut Oil Sodium Bicarbonate Alcohol Benzyl Alcohol Hydrated Silica Lecithin, Soybean Poloxamer 407 Medium-chain Triglycerides Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-11-01

Description

Menthol 0.5%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

For the temporary relief of pain

Dosage and Administration

Shake well. 15 minutes to 2 hours before your workout, apply generously to the muscles you use most (30 minutes before water sports). Completely cover each muscle, a palmful per use. Reapply after for added recovery. Wash hands.

Adults and children 2 years of age or older: apply to affected area not more than 3 to 4 times daily

Children under 2 years of age: consult a doctor

Description

Menthol 0.5%

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 doctor if:

Symptoms persist for more than 7 days

Symptoms clear up and occur again within a few days

Section 50567-7

Use only as directed. Avoid contact with eyes.

Section 50570-1

Do not use if allergic to any ingredient in this product or sensitive to sodium

Section 51727-6

sodium bicarbonate, water, isopropyl palmitate, lecithin, poloxamer 407, alcohol denat., benzyl alcohol, polygylceryl-4 laurate, hydrated silica, cocos nucifera (coconut) oil, simmondsia chinensis (jojoba) seed oil, caprylic/capric triglyceride, sodium hydroxide, fragrance

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use

Section 55105-1

Pain relieving sports lotion

Section 55106-9

Menthol 0.5%

Section 60561-8

Store at 20-25C (68-77F)

Pr Lotion 100 Gram Tube Principal Display Panel

Pr Lotion 300 Gram Tube Principal Display Panel

Pr Lotion 20 Gram Packet Principal Display Panel


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of pain

Dosage and Administration (34068-7)

Shake well. 15 minutes to 2 hours before your workout, apply generously to the muscles you use most (30 minutes before water sports). Completely cover each muscle, a palmful per use. Reapply after for added recovery. Wash hands.

Adults and children 2 years of age or older: apply to affected area not more than 3 to 4 times daily

Children under 2 years of age: consult a doctor

Warnings and Precautions (34071-1)

For external use only

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 doctor if:

Symptoms persist for more than 7 days

Symptoms clear up and occur again within a few days

Section 50567-7 (50567-7)

Use only as directed. Avoid contact with eyes.

Section 50570-1 (50570-1)

Do not use if allergic to any ingredient in this product or sensitive to sodium

Section 51727-6 (51727-6)

sodium bicarbonate, water, isopropyl palmitate, lecithin, poloxamer 407, alcohol denat., benzyl alcohol, polygylceryl-4 laurate, hydrated silica, cocos nucifera (coconut) oil, simmondsia chinensis (jojoba) seed oil, caprylic/capric triglyceride, sodium hydroxide, fragrance

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use

Section 55105-1 (55105-1)

Pain relieving sports lotion

Section 55106-9 (55106-9)

Menthol 0.5%

Section 60561-8 (60561-8)

Store at 20-25C (68-77F)

Pr Lotion 100 Gram Tube Principal Display Panel (PR Lotion 100 gram tube principal display panel)

Pr Lotion 300 Gram Tube Principal Display Panel (PR Lotion 300 gram tube principal display panel)

Pr Lotion 20 Gram Packet Principal Display Panel (PR Lotion 20 gram packet principal display panel)


Advanced Ingredient Data


Raw Label Data

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