SPL v2
SPL
SPL Set ID df540eb8-6773-4647-9cc2-c3fd14d7355e
Route
TOPICAL
Published
Effective Date 2018-05-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (20 g) Resorcinol (3 g)
Inactive Ingredients
Isopropyl Palmitate Lanolin Methylparaben Mineral Oil Petrolatum Propylene Glycol Retinol Sodium Lauryl Sulfate Sodium Sulfate Tocopherol Water Aloe Vera Leaf Cetyl Alcohol Cholecalciferol Edetic Acid Glyceryl Monostearate Isopropyl Myristate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-08-20

Description

Active ingredients Benzocaine  20% Resorcinol  3%


Medication Information

Warnings and Precautions

. Warnings For external use only

avoid contact When using this product

with the eyes.

if condition Stop use and ask a doctor

worsens, or if symptoms persists for

more than 7 days or clear up and occur

again within a few days.

over large areas of the body. Do not apply

Indications and Usage

temporarily relieves itching Uses

Dosage and Administration

Directions

Adults and children 12 years and older:

apply a fingertip amount (approximately

1 inch strip) to the affected area not

more than 3 to 4 times daily.

•: ask a doctor Children udner 12 years

Description

Active ingredients Benzocaine  20% Resorcinol  3%

Section 44425-7

Other information

Atore at 20° -  25°  C (68° -  77° F).

Section 50565-1

. If Keep out of reach of children

swallowed, get medical help or contact

a Poison Control Center right away.

Section 51727-6

Inactive ingredients

Aloe barbadensis leaf juice,

Cetyl alcohol, Cholecalciferol,

EDTA, Fragrance, Glyceryl

stearate, Isopropyl myristate,

Isopropyl palmitate, Lanolin,

Methylparaben, Mineral Oil,

Petrolatum, Propylene glycol,

Retinol, Sodium lauryl sulfate,

Sodium Sulfate, Tocopherol,

Water

Section 51945-4

Section 55105-1

Purpose

External Analgesic

External Analgesic

Section 55106-9

Active ingredients

Benzocaine  20%

Resorcinol  3%


Structured Label Content

Indications and Usage (34067-9)

temporarily relieves itching Uses

Dosage and Administration (34068-7)

Directions

Adults and children 12 years and older:

apply a fingertip amount (approximately

1 inch strip) to the affected area not

more than 3 to 4 times daily.

•: ask a doctor Children udner 12 years

Warnings and Precautions (34071-1)

. Warnings For external use only

avoid contact When using this product

with the eyes.

if condition Stop use and ask a doctor

worsens, or if symptoms persists for

more than 7 days or clear up and occur

again within a few days.

over large areas of the body. Do not apply

Section 44425-7 (44425-7)

Other information

Atore at 20° -  25°  C (68° -  77° F).

Section 50565-1 (50565-1)

. If Keep out of reach of children

swallowed, get medical help or contact

a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients

Aloe barbadensis leaf juice,

Cetyl alcohol, Cholecalciferol,

EDTA, Fragrance, Glyceryl

stearate, Isopropyl myristate,

Isopropyl palmitate, Lanolin,

Methylparaben, Mineral Oil,

Petrolatum, Propylene glycol,

Retinol, Sodium lauryl sulfate,

Sodium Sulfate, Tocopherol,

Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

External Analgesic

External Analgesic

Section 55106-9 (55106-9)

Active ingredients

Benzocaine  20%

Resorcinol  3%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)