Active Ingredients
Menthol 0.35%
Petrolatum 79.65%
Zinc Oxide 5.00%
Asteroid Ointment
FDA Label NDC 84107-552
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Healthtex Limited for the product Asteroid (NDC 84107-552). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purposes, uses, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Anesthetic/Antipruritic/Analgesic
Protectant
Astringent
Uses
- helps relieve burning, soreness, and itching by providing rapid acting cooling barrier ointment for external hemorrhoids and minor anal irritation.
Warnings
For external use only.
Do Not Use
Do not use if you are bleeding from the anal region.
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.
Directions
- Adults: Apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.
Other Information
Store at room temperature 68°-77°F (20°-25°C)
Inactive Ingredients
Cocoa Butter, Petrolatum.
Questions?
1-800-819-9676 or visit neoqura.com
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)
Figure (Ast07 0001 01)
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)
Figure (Ast07 0001 02)
* Please review the disclaimer below.
