Humane Acne Spot Treatment Gel
FDA Label NDC 73010-127

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Apprendista, Llc for the product Humane Acne Spot Treatment (NDC 73010-127). 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 drug facts, active ingredient, purpose, use, warnings, do not use if you, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Benzoyl Peroxide 5%

Purpose

Acne Treatment

Use

for the treatment of acne.

Warnings

For external use only.

Do Not Use If You

  • are sensitive to benzoyl peroxide 
  • have very sensitive skin.

When Using This Product

  • Skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • Avoid unnecessary sun exposure and use a sunscreen. 
  • Avoid contact with eyes, lips and mouth. Avoid product contact with hair and dyed fabrics, which may be bleached by this product.
  • Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop Use And Ask A Doctor

if irritation becomes severe.

Keep Out Of Reach Of Children:

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

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Directions

  • Clean the skin thoroughly before applying this product. 
  • Cover the entire affected area with a thin layer one to three times daily. 
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. 
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Inactive Ingredients

a-Bisabalol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water),
Caprylyl Glycol, Cucumis Sativus (Cucumber) Extract, Glycyrrhiza Glabra (Licorice) Extract, Hexylene Glycol, Menthyl Lactate, Phenoxyethanol, Polysorbate-20, Potassium Sorbate, Propylene Glycol, Sodium Hydroxide

Questions?

thehumanecompany.com

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