Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 29d1e46d-0189-4f9e-9963-8a9de2757f28
Route
TOPICAL
Published
Effective Date 2025-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.098 g) Petrolatum (22.302 g) Zinc Oxide (1.4 g)
Inactive Ingredients
Cocoa Butter

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-22

Description

Menthol 0.35% Petrolatum 79.65% Zinc Oxide 5.00%

Purpose

Anesthetic/Antipruritic/Analgesic Protectant Astringent


Medication Information

Purpose

Anesthetic/Antipruritic/Analgesic Protectant Astringent

Description

Menthol 0.35% Petrolatum 79.65% Zinc Oxide 5.00%

Uses
  • helps relieve burning, soreness, and itching by providing rapid acting cooling barrier ointment for external hemorrhoids and minor anal irritation.
Purposes

Anesthetic/Antipruritic/Analgesic

Protectant

Astringent

Warnings

For external use only.

Directions
  • Adults: Apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.
Do Not Use

Do not use if you are bleeding from the anal region.

Questions?

1-800-819-9676 or visit neoqura.com

Other Information

Store at room temperature 68°-77°F (20°-25°C)

Active Ingredients

Menthol 0.35%

Petrolatum 79.65%

Zinc Oxide 5.00%

Inactive Ingredients

Cocoa Butter, Petrolatum.

When Using This Product
  • Do not exceed the recommended daily dosage unless directed by the doctor.
  • Do not put into rectum by using fingers or any mechanical device or applicator.
  • Possible side effects may include a brief cooling or heating sensation on application.
Stop Use and Ask A Doctor If
  • If allergic to the ointment or any of it's ingredients
  • Bleeding occurs in the anal region
  • Condition worsens or does not improve within 7 days.
If Pregnant Or Breast Feeding

Do not use if pregnant or breastfeeding.

Keep Out of Reach of Children

If swallowed, get medical help, or contact a Poison Control Center right away.

Principal Display Panel – 28 G Tube Label

neoqura

asteroid™

ointment

Hemorrhoid

formulation

Rapid acting cooling

barrier ointment for

burning soreness and

itching associated with

external hemorrhoids and

minor anal irritation.

+ COOLS

+ SOOTHES

+ PROTECTS

1 TUBE NET WT 1.0 OZ (28 g)

Principal Display Panel – 28 G Carton Label

NDC 84107-552-02

neoqura

asteroid™

ointment

Hemorrhoid

formulation

Rapid acting cooling

barrier ointment for

burning soreness and

itching associated

with external

hemorrhoids and

minor anal irritation.

+ COOLS

+ SOOTHES

+ PROTECTS

1 TUBE | NET WT 1.0 OZ (28 g)


Structured Label Content

Uses
  • helps relieve burning, soreness, and itching by providing rapid acting cooling barrier ointment for external hemorrhoids and minor anal irritation.
Purposes

Anesthetic/Antipruritic/Analgesic

Protectant

Astringent

Warnings

For external use only.

Directions
  • Adults: Apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.
Do Not Use

Do not use if you are bleeding from the anal region.

Questions?

1-800-819-9676 or visit neoqura.com

Other Information (Other information)

Store at room temperature 68°-77°F (20°-25°C)

Active Ingredients

Menthol 0.35%

Petrolatum 79.65%

Zinc Oxide 5.00%

Inactive Ingredients (Inactive ingredients)

Cocoa Butter, Petrolatum.

When Using This Product (When using this product)
  • Do not exceed the recommended daily dosage unless directed by the doctor.
  • Do not put into rectum by using fingers or any mechanical device or applicator.
  • Possible side effects may include a brief cooling or heating sensation on application.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • If allergic to the ointment or any of it's ingredients
  • Bleeding occurs in the anal region
  • Condition worsens or does not improve within 7 days.
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

Do not use if pregnant or breastfeeding.

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help, or contact a Poison Control Center right away.

Principal Display Panel – 28 G Tube Label (Principal Display Panel – 28 g Tube Label)

neoqura

asteroid™

ointment

Hemorrhoid

formulation

Rapid acting cooling

barrier ointment for

burning soreness and

itching associated with

external hemorrhoids and

minor anal irritation.

+ COOLS

+ SOOTHES

+ PROTECTS

1 TUBE NET WT 1.0 OZ (28 g)

Principal Display Panel – 28 G Carton Label (Principal Display Panel – 28 g Carton Label)

NDC 84107-552-02

neoqura

asteroid™

ointment

Hemorrhoid

formulation

Rapid acting cooling

barrier ointment for

burning soreness and

itching associated

with external

hemorrhoids and

minor anal irritation.

+ COOLS

+ SOOTHES

+ PROTECTS

1 TUBE | NET WT 1.0 OZ (28 g)


Advanced Ingredient Data


Raw Label Data

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