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
Tiege Hanley Acne All Over Body Aerosol, Spray
FDA Label NDC 71714-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tiege Hanley for the product Tiege Hanley Acne All Over Body (NDC 71714-005). 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 - keep out of reach of children, dosage & administration, otc - purpose, otc - active ingredient, otc - stop use, inactive ingredient, indications & usage, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage & Administration
Directions
■ clean the skin thouroughly before applying this product
■ cover the entire affected area with a thin layer one to three times daily
■ because of excessive drying of the skin may occur, start with one application daily, then gradually increase to two times daily, then gradually increase to 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
■ see the Best Use section for more information on how to use for optimal results.
Otc - Purpose
Purpose.......Acne Treatment
Otc - Active Ingredient
Salicylic Acid 2%
Otc - Stop Use
Stop use and ask a doctor if irritation
becomes severe.
Inactive Ingredient
Inactive Ingredients:
Water/Aqua/Eau, Propanediol, Alcohol Denat, Niacinamide, Phenoxyethanol, Saccharide Isomerate, Sodium Hydroxide, Ethylhexylglycerin, Aloe Barbadensis Leaf Juice, t-Butyl Alcohol, Citric Acid, Sodium Citrate, Denatonium Benzoate
Indications & Usage
Uses ■ For the management of acne
Warnings
Warnings
■ For External Use Only
When using this product ■ skin irritation
and dryness is 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 spraying in eyes ■ Contents under pressure.
Do not puncture or incinerate. Do not store at a
temperature above 120°F11(49°C) or below 40°F11(5°C}.
Do not use if you ■ have very sensitive
skin ■ are sensitive to salicylic acid
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
* Please review the disclaimer below.
