Myderm Bite Relief Mediocated Ointment

SPL v3

SPL

SPL Set ID 88615668-16b5-7840-e053-2a95a90a9208

Route

TOPICAL

Published

Effective Date 2021-12-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzocaine (5 g)

Inactive Ingredients

Peg-8 Dimethicone Peppermint Propylparaben Water Peg-2 Stearate Edetic Acid Camphor (natural) Matricaria Chamomilla Flowering Top Oil Clove Oil Propylene Glycol 1,2-distearate Olea Europaea (olive) Oil Unsaponifiables Aloe Methylparaben Diazolidinyl Urea Alcohol Medium Density Polyethylene Menthol Hydrocortisone

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-12-14

Description

Active Ingredient: Benzocaine - 5.0%

Medication Information

Warnings and Precautions

For external use only

When using this product • avoid contact with the eye

Indications and Usage

Temporary relief of pain and itching associated with insect bites

Dosage and Administration

Direction Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: consult a physician

Description

Active Ingredient: Benzocaine - 5.0%

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 a doctor if • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 51727-6

Aloe Barbadensis Leaf Extract

Camphor

Chamomilla Recutita (Matricaria) Flower Extract

Diazolidinyl Urea

Disodium EDTA

Eugenia Caryophyllus (Clove) Flower Oil

Hydrocortisone

Inactive Ingredients:

Mentha Piperita (Peppermint) Oil

Menthol

Methylparaben

Olea Europaea (Olive) Fruit Oil

Papain

PEG-2 Stearate

PEG-2 Stearate SE

Polyethylene

Propylene Glycol

Propylparaben

SD Alcohol 40

Water

Section 51945-4

Section 55105-1

Benzocaine - 10.0% ............Pain Relief

Section 55106-9

Active Ingredient:

Benzocaine - 5.0%

Structured Label Content

Indications and Usage (34067-9)

Temporary relief of pain and itching associated with insect bites

Dosage and Administration (34068-7)

Direction Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: consult a physician

Warnings and Precautions (34071-1)

For external use only

When using this product • avoid contact with the eye

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 a doctor if • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 51727-6 (51727-6)

Aloe Barbadensis Leaf Extract

Camphor

Chamomilla Recutita (Matricaria) Flower Extract

Diazolidinyl Urea

Disodium EDTA

Eugenia Caryophyllus (Clove) Flower Oil

Hydrocortisone

Inactive Ingredients:

Mentha Piperita (Peppermint) Oil

Menthol

Methylparaben

Olea Europaea (Olive) Fruit Oil

Papain

PEG-2 Stearate

PEG-2 Stearate SE

Polyethylene

Propylene Glycol

Propylparaben

SD Alcohol 40

Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Benzocaine - 10.0% ............Pain Relief

Section 55106-9 (55106-9)

Active Ingredient:

Benzocaine - 5.0%

Advanced Ingredient Data

[{"name": "PEG-8 DIMETHICONE", "unii": "GIA7T764OD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEPPERMINT", "unii": "V95R5KMY2B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZOCAINE", "unii": "U3RSY48JW5", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-2 STEARATE", "unii": "94YQ11Y95F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETIC ACID", "unii": "9G34HU7RV0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAMPHOR (NATURAL)", "unii": "N20HL7Q941", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MATRICARIA CHAMOMILLA FLOWERING TOP OIL", "unii": "SA8AR2W4ER", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CLOVE OIL", "unii": "578389D6D0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL 1,2-DISTEARATE", "unii": "T65PN3O37H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES", "unii": "XO45V955LT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE", "unii": "V5VD430YW9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIAZOLIDINYL UREA", "unii": "H5RIZ3MPW4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MEDIUM DENSITY POLYETHYLENE", "unii": "3W404QE89S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROCORTISONE", "unii": "WI4X0X7BPJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Temporary relief of pain and itching associated with insect bites", "34068-7": "Direction Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician", "34071-1": "For external use only When using this product • avoid contact with the eye", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "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.", "51727-6": "Aloe Barbadensis Leaf Extract Camphor Chamomilla Recutita (Matricaria) Flower Extract Diazolidinyl Urea Disodium EDTA Eugenia Caryophyllus (Clove) Flower Oil Hydrocortisone Inactive Ingredients: Mentha Piperita (Peppermint) Oil Menthol Methylparaben Olea Europaea (Olive) Fruit Oil Papain PEG-2 Stearate PEG-2 Stearate SE Polyethylene Propylene Glycol Propylparaben SD Alcohol 40 Water", "55105-1": "Benzocaine - 10.0% ............Pain Relief", "55106-9": "Active Ingredient: Benzocaine - 5.0%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:27.688212 · Updated: 2026-03-14T23:07:19.548615