BALANCING ACT- salicylic acid liquid 
Parea, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient

Salicylic acid  0.5%

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

BALANCING ACT 
salicylic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83360-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
MANDELIC ACID (UNII: NH496X0UJX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
NIACINAMIDE (UNII: 25X51I8RD4)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
SODIUM ACRYLATES CROSSPOLYMER-2 (UNII: D3HPR4WW6F)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
GLYCERIN (UNII: PDC6A3C0OX)  
ZINC PIDOLATE (UNII: C32PQ86DH4)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SYRINGA VULGARIS POLLEN (UNII: 2BO2QL8OR1)  
MILK THISTLE (UNII: U946SH95EE)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
WHITE TEA (UNII: O0M3396E09)  
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
SALIX ALBA BARK (UNII: 205MXS71H7)  
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
PANTHENOL (UNII: WV9CM0O67Z)  
ALLANTOIN (UNII: 344S277G0Z)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83360-001-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product04/06/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D04/06/2023
Labeler - Parea, Inc. (118943804)

Revised: 4/2023
Document Id: f89da869-8ec3-03da-e053-6294a90aeb90
Set id: 9845c715-9409-42d3-b542-951c5e60962d
Version: 2
Effective Time: 20230405
 
Parea, Inc.