31c2cd25-1fec-5ec5-e063-6394a90a24b4

SPL v2
SPL
SPL Set ID 31c2cd25-1fec-5ec5-e063-6394a90a24b4
Route
topical
Published
Effective Date 2025-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
glycerin (20 mg) benzocaine
Inactive Ingredients
hamamelis virginiana root bark/stem bark potassium sorbate aloe barbadensis leaf juice citric acid sodium benzoate alcohol 95% dimethyl ether polyethylene glycol 300 ppg-3 methyl ether

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-08-15

Purpose

Local anesthetic Protectant

Description

Directions Adults: •When practical, cleanse the affected area with mild soap and warm water, and rinse thoroughly. •Gently pat dry before use. •Hold the can upside-down and point spray nozzle 6 to 12 inches from affected area. •Apply externally up to 6 times daily or after each bowel movement. Children under 12 years of age: consult a doctor.


Medication Information

Warnings and Precautions

Warnings

For extemal use only

FLAMMABLE. Do not use near heat,

flame, or fire or wlile smoking.

When using this product ■ Use only as

directed. ■ Do not exceed recommended

daily dosage unless directed by a doctor.

■ Intentional misuse by deliberately

concentrating or inhaling the contents

can be hmmful or fatal. ■ Do not put this

product into the rectum by using fingers

or any mechanical device or applicator.

Stop use and ask a doctor if

■ Condition worsens or does not improve

within 7 days. ■ Bleeding occurs

■ Certain persons can develop allergic

reactions to ingredients in this product. If the

symptoms being treated does not subside or if

redness, irritation, swelling, pain, or other

syptoms develop or increase, discontinue

use and consult a doctor. ■ Avoid spaying in

eyes. ■ Contents under pressure. Do not

puncture or incinerate. ■ Do not store at

temperature above 120ºF. Keep out of reach

of children. ■ If swallowed, get medical help

or contact a Poison Control Cerier right away.

Uses

■ Helps relieve discomfort

in the perianal area. ■ Temporarily protects

inflamed perianal skin.

Purpose

Local anesthetic

Protectant

Dosage and Administration

Directions

Adults: •When practical, cleanse the affected area with mild soap and warm water, and rinse thoroughly. •Gently pat dry before use. •Hold the can upside-down and point spray nozzle 6 to 12 inches from affected area. •Apply externally up to 6 times daily or after each bowel movement.

Children under 12 years of age: consult a doctor.

Inactive Ingredients

aloe barbadensis leaf juice, citric acid, dimethyl ether, dipropylene glycol, ethanol, polyethylene glycol, potassium sorbate, PPG-3 methyl ether, sodium benzoate, witch hazel extract

Description

Directions Adults: •When practical, cleanse the affected area with mild soap and warm water, and rinse thoroughly. •Gently pat dry before use. •Hold the can upside-down and point spray nozzle 6 to 12 inches from affected area. •Apply externally up to 6 times daily or after each bowel movement. Children under 12 years of age: consult a doctor.

Section 50565-1

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

Section 51945-4

Upside Sown Pain Relief Spray

3.5 oz


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For extemal use only

FLAMMABLE. Do not use near heat,

flame, or fire or wlile smoking.

When using this product ■ Use only as

directed. ■ Do not exceed recommended

daily dosage unless directed by a doctor.

■ Intentional misuse by deliberately

concentrating or inhaling the contents

can be hmmful or fatal. ■ Do not put this

product into the rectum by using fingers

or any mechanical device or applicator.

Stop use and ask a doctor if

■ Condition worsens or does not improve

within 7 days. ■ Bleeding occurs

■ Certain persons can develop allergic

reactions to ingredients in this product. If the

symptoms being treated does not subside or if

redness, irritation, swelling, pain, or other

syptoms develop or increase, discontinue

use and consult a doctor. ■ Avoid spaying in

eyes. ■ Contents under pressure. Do not

puncture or incinerate. ■ Do not store at

temperature above 120ºF. Keep out of reach

of children. ■ If swallowed, get medical help

or contact a Poison Control Cerier right away.

Uses

■ Helps relieve discomfort

in the perianal area. ■ Temporarily protects

inflamed perianal skin.

Purpose

Local anesthetic

Protectant

Dosage and Administration (34068-7)

Directions

Adults: •When practical, cleanse the affected area with mild soap and warm water, and rinse thoroughly. •Gently pat dry before use. •Hold the can upside-down and point spray nozzle 6 to 12 inches from affected area. •Apply externally up to 6 times daily or after each bowel movement.

Children under 12 years of age: consult a doctor.

Inactive Ingredients

aloe barbadensis leaf juice, citric acid, dimethyl ether, dipropylene glycol, ethanol, polyethylene glycol, potassium sorbate, PPG-3 methyl ether, sodium benzoate, witch hazel extract

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 51945-4 (51945-4)

Upside Sown Pain Relief Spray

3.5 oz


Advanced Ingredient Data


Raw Label Data

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