SPL v1
SPL
SPL Set ID 42513ee2-8b40-a9f3-e063-6394a90a9386
Route
TOPICAL
Published
Effective Date 2025-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1.1 mg)
Inactive Ingredients
Potassium Sorbate Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Brazilian Pepper Sodium Bicarbonate Edetate Disodium Dimethicone/peg-10/15 Crosspolymer Water Sodium Hydroxide Actinidia Deliciosa (kiwi) Fruit Ceanothus Americanus Leaf Dimethicone Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Citric Acid Licorice Bromelain Nisin Cyclopentasiloxane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-15

Description

Active ingredient Purpose Menthol, 0.11%...........Topical analgesic, antipruritic


Medication Information

Warnings and Precautions

Warnings

For external use only.

Avoid contact with eyes.

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product & consult a doctor.

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

Indications and Usage

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 or 4 times daily. Children under 2 years of age: Do not use, consult a doctor.

Dosage and Administration

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 or 4 times daily. Children under 2 years of age: Do not use, consult

a doctor.

Description

Active ingredient Purpose Menthol, 0.11%...........Topical analgesic, antipruritic

Section 44425-7

Other information

Protect this product from excessive heat and sun.

Do not use if seal is broken.

Section 50565-1

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

Section 50567-7

Warnings

For external use only.

Avoid contact with eyes.

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product & consult a doctor.

Section 51727-6

Inactive ingredients

Water, Cyclopentasiloxane, Dimethicone, Dimethi- cone/PEG-10/15 Crosspolymer, Potassium Sorbate, Dimethicone/Vinyl Dimethicone Crosspolymer, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Actinidia Deliciosa, Brazilian Peppertree Extract (Schinus terebinthifolius), Red Root Extract (Ceanothus americanus), Licorice Root Extract, Bromelain, Nisin, Sodium Bicarbonate, Disodium EDTA, Sodium Hydroxide, Citric Acid.

Section 51945-4

Benova®

Pain & Itch

Relief Lotion

+Immediate Relief

+Steroid-Free Relief

+Gentle On Sensitive Skin

3 FL OZ (90 mL)

See uploaded image Benova_PainItchReliefLotion_3floz_PeelBack_FullLabel.jpg.

Section 55105-1

Uses

For temporary relief of pain & itching associated with insect bites, sunburn, minor cuts, scrapes, minor skin irritations, and fever blisters & cold sores.

Section 55106-9

Active ingredient Purpose

Menthol, 0.11%...........Topical analgesic, antipruritic


Structured Label Content

Indications and Usage (34067-9)

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 or 4 times daily. Children under 2 years of age: Do not use, consult a doctor.

Dosage and Administration (34068-7)

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 or 4 times daily. Children under 2 years of age: Do not use, consult

a doctor.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Avoid contact with eyes.

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product & consult a doctor.

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

Section 44425-7 (44425-7)

Other information

Protect this product from excessive heat and sun.

Do not use if seal is broken.

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

Warnings

For external use only.

Avoid contact with eyes.

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product & consult a doctor.

Section 51727-6 (51727-6)

Inactive ingredients

Water, Cyclopentasiloxane, Dimethicone, Dimethi- cone/PEG-10/15 Crosspolymer, Potassium Sorbate, Dimethicone/Vinyl Dimethicone Crosspolymer, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Actinidia Deliciosa, Brazilian Peppertree Extract (Schinus terebinthifolius), Red Root Extract (Ceanothus americanus), Licorice Root Extract, Bromelain, Nisin, Sodium Bicarbonate, Disodium EDTA, Sodium Hydroxide, Citric Acid.

Section 51945-4 (51945-4)

Benova®

Pain & Itch

Relief Lotion

+Immediate Relief

+Steroid-Free Relief

+Gentle On Sensitive Skin

3 FL OZ (90 mL)

See uploaded image Benova_PainItchReliefLotion_3floz_PeelBack_FullLabel.jpg.

Section 55105-1 (55105-1)

Uses

For temporary relief of pain & itching associated with insect bites, sunburn, minor cuts, scrapes, minor skin irritations, and fever blisters & cold sores.

Section 55106-9 (55106-9)

Active ingredient Purpose

Menthol, 0.11%...........Topical analgesic, antipruritic


Advanced Ingredient Data


Raw Label Data

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