Active Ingredient
Salicylic acid 0.5%
Balancing Act
FDA Label NDC 83360-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Parea, Inc. for the product Balancing Act (NDC 83360-001). 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, direction, inactive ingredients, other information, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Acne treatment
Uses
For the treatment of acne.
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 contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Stop use and ask doctor if skin irritation occurs.
Keep out of reach of children. If product is swallowed get medical help or contact a poison control center right away.
Direction
After cleansing, apply one to two pumps on dry skin. Cover your entire face, not just the visible acne, and avoid the eye area. Let it dry before applying other products. Because irritation or excessive drying of the skin may occur, start with one application every other day, and work up to using daily. Follow with SPF when using in the morning. Reduce application if irritation occurs.
Inactive Ingredients
water, diethylene glycol monoethyl ether, mandelic acid, butylene glycol, lactic acid, unspecified form, niacinamide, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer(100000 mpa.s at 1.5%), sodium acrylates crosspolymer-2, sodium pyrrolidone carboxylate, hyaluronate sodium, glycerin, zinc pidolate, gluconolactone, maltodextrin, polysorbate 20, lecithin, soybean, syringa vulgaris pollen, milk thistle, green tea leaf, white tea, aspalathus linearis leaf, glycyrrhiza glabra, centella asiatica triterpenoids, asian ginseng, salix alba bark, arctium lappa root, azadirachta indica leaf, sunflower oil, glycyrrhizinate dipotassium, panthenol, allantoin, tocopherol, sodium hydroxide, caprylyl glycol, ethylhexylglycerin, hexylene glycol, phenoxyethanol, sodium benzoate, potassium sorbate, sorbitan isostearateonic
Other Information
Made in USA
Distributed by Parea, Inc.
New York, NY 10013 USA
becoolasacucumber.com
Product Label
Image Description (Image 1)
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