Alubri Cream
FDA Label NDC 87941-100

13 label sections · Submitted to the FDA by Venus Health Science, Inc. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Venus Health Science, Inc. for the product Alubri (NDC 87941-100). 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 ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Otc - Keep Out Of Reach Of Children

→ Directions:

→ Inactive Ingredients:

→ Other Information:

→ Principal Display Panel - 50 Ml Carton Label

→ Principal Display Panel - 30 Ml Tube Label

Active Ingredient

Hydrocortisone 0.25%

Purpose

Anti-Itch Cream

Uses

For the temporary relief of external feminine itching associated with minor skin irritations, inflammation, and rashes.
Other uses of this product should be only under the advice and supervision of a doctor.

Warnings

For external use only

Do Not Use

if you have a vaginal discharge. Consult a doctor.
if you are allergic to any ingredient in this product.

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor If

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

Otc - 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.

Directions:

Adults and children 12 years of age and older: Apply to external vaginal area not more than 3 to 4 times daily.
Children under 12 years of age: Consult a doctor.

Inactive Ingredients:

Aqua (Water, Eau), Propanediol, Cetearyl Alcohol, Isopropyl Palmitate, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglycerides, Dimethicone, Cocos Nucifera (Coconut) Oil, Glyceryl Stearate, Hydrolyzed Rosa Canina Fruit Oil, Hydrolyzed Cocos Nucifera (Coconut) Oil, Sodium Hyaluronate, Lactic Acid, Avena Sativa (Oat) Meal Extract, Tocopherol, Aloe Barbadensis Leaf Juice, Lactobacillus Ferment Lysate, Hydrogenated Lecithin, Cetearyl Glucoside, Sclerotium Gum, Dimethicone Crosspolymer, Xanthan Gum, Ethylhexylglycerin, Butylene Glycol, Phenoxyethanol, Isododecane, Glycerin.