Deep Cover Bug Bite Relief

Deep Cover Bug Bite Relief
SPL v1
SPL
SPL Set ID 25010dd6-fb48-8ee7-e063-6394a90aee6c
Route
TOPICAL
Published
Effective Date 2024-10-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (10 g)
Inactive Ingredients
Lemongrass Oil Camphor (synthetic) Peg-2 Stearate Clove Oil Matricaria Chamomilla Flowering Top Oil Propylene Glycol Peppermint Oil .alpha.-tocopherol Acetate Vitamin A Palmitate Aloe Vera Leaf Diazolidinyl Urea Propylparaben Edetate Disodium Ascorbic Acid Olive Oil Methylparaben Water Cholecalciferol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-24

Description

Benzocaine 10%


Medication Information

Warnings and Precautions

For external use only.

When using this product avoid contact with eyes. Stop use and ask a doctor if the condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days.

Indications and Usage

Adults and children 2 years and older: apply to the affected area, not more than 3 to 4 times daily. Children under 2 years of age: ask a doctor.

Dosage and Administration

Uses: for the temporary relief of pain and itching associated with chigger bites, red bug bites, ticks, and mosquito bites.

Description

Benzocaine 10%

Section 50565-1

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Section 51727-6

Water, PEG-2 Stearate, Olea Europaea (Olive) Fruit Extract, Mentha Piperita (Peppermint) Oil, Aloe Barbadensis Leaf Extract, Camphor, Eugenia Caryophyllus (Clove) Flower Oil, Chamomilla Recutita (Matricaria) Flower Extract, Propylene Glycol, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Cholecalciferol, Fragrance, Methylparaben, Propylparaben, Diazolidinyl Urea, Disodium EDTA, Cymbopogon Flexuosus (Lemongrass) Oil,

Section 51945-4

Section 55105-1

Pain Relief

Section 55106-9

Benzocaine 10%


Structured Label Content

Indications and Usage (34067-9)

Adults and children 2 years and older: apply to the affected area, not more than 3 to 4 times daily. Children under 2 years of age: ask a doctor.

Dosage and Administration (34068-7)

Uses: for the temporary relief of pain and itching associated with chigger bites, red bug bites, ticks, and mosquito bites.

Warnings and Precautions (34071-1)

For external use only.

When using this product avoid contact with eyes. Stop use and ask a doctor if the condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50565-1 (50565-1)

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Section 51727-6 (51727-6)

Water, PEG-2 Stearate, Olea Europaea (Olive) Fruit Extract, Mentha Piperita (Peppermint) Oil, Aloe Barbadensis Leaf Extract, Camphor, Eugenia Caryophyllus (Clove) Flower Oil, Chamomilla Recutita (Matricaria) Flower Extract, Propylene Glycol, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Cholecalciferol, Fragrance, Methylparaben, Propylparaben, Diazolidinyl Urea, Disodium EDTA, Cymbopogon Flexuosus (Lemongrass) Oil,

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Pain Relief

Section 55106-9 (55106-9)

Benzocaine 10%


Advanced Ingredient Data


Raw Label Data

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