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| Product NDC Code | 83360-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Balancing act |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 199308 | ||||
| Application Number | part333D | ||||
| Labeler Name | Parea, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Salicylic acid 0.5%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses For the treatment of acne.
Purpose
Information about the drug product’s indications for use.Purpose Acne treatment
Spl product data elements
Usually a list of ingredients in a drug product.Balancing Act Salicylic acid 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 ISOSTEARATE SALICYLIC ACID SALICYLIC ACID
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Product label image description
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other information Made in USA Distributed by Parea, Inc. New York, NY 10013 USA becoolasacucumber.com
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API