Acne Tonic Liquid
FDA Label NDC 61096-1027

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Eight And Company L.l.c for the product Acne Tonic (NDC 61096-1027). 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 otc - active ingredient, warnings, otc - keep out of reach of children, dosage & administration, otc - purpose, other safety information, inactive ingredient, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients: Anthracinum 200C, Antimonium crudum 30C, Apis mellifica 4X, Carbo animalis 12X, Hamamelis virginiana 3X, Hepar suis 6X, Hydrocotyle asiatica 30C, Kali bromatum 30C, Mercurius corrosivus 200C, Natrum sulphuratum 200C, Pyrogenium 30C, Radium bromatum 200C, Sanguinaria canadensis 3X, Sulphur iodatum 200C, Thuja occidentalis 200C, Urtica urens 3X

Warnings

Warnings: If symptoms persist or worsen, seek advice of physician. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage & Administration

Directions:

  • Adults and children over 12: 2 sprays into the mouth 3 times per day.
  • Ages 2 to 12: 1 spray into the mouth 3 times per day.
  • Under age 2: consult a health care professional.

Otc - Purpose

Temporarily relieves acne discomfort and the common symptoms of acne, including:

  • Face and body breakouts
  • redness
  • itching and inflammation

Other Safety Information

Other Information: Do not use if the transparent seal around spray bottle is broken or missing.

Inactive Ingredient

Inactive Ingredients: Glycerin 10% v/v, non-GMO organic alcohol 9% v/v and purified water.

Indications & Usage

Temporarily relieves acne discomfort and the common symptoms of acne, including:

° face and body breakouts

° redness

° itching and inflammation

° natural

° gluten free

° no artificial flavors or colors

° no known negative side effects

° no known negative drug interactions

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