Label: EMERGENCY ZIT TREATMENT ACNE- salicylic acid stick
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Contains inactivated NDC Code(s)
NDC Code(s): 61084-125-01, 61084-125-02 - Packager: Basic Research
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated April 17, 2015
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredient Purpose
Salicylic Acid 2% Acne Treatment Cream
Uses
Treats acne
Clears up acne blemishes
Penetrates Pores to clear most acne pimples
Keep out of reach of children. If swallowed get medical or contact a Poison Control Center right away. If swallowed get medical help or contact a poison control center right away.
Do not use on broken skin or apply to large areas of the body
Warnings
For external use only
Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. if this occurs only one medication should be used unless directed by a physician.
Apply to effected areas only
Directions
Cleanse the skin thoroughly before applying this medication.
Cover the entire affected area with a thin layer one to three times daily.
Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three time 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.
Inactive ingredients
Water (Aqua), Butylene Glycol, Cetearyl Alcohol, Cetyl Alcohol, Glycerin, Steareth-2, Oleth-10, Caprylic/Capric Triglyceride, Octyldodecanol, Caprylyl Methicone,Bakuchiol, Hydrolyzed Optunia Ficus-Indica Flower Extract, Boerhavia Diffusia Root Extract, Allantoin, Sodium Hyaluronate, Dicetyl Phophate, C18-21 Alkane, Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer, Caprylyl Glycol, Xanthan Gum, Glyceryl Acrylate/Acrylic Acid Copolymer, Squalane, Ethylhexylglycerin, Polysorbate 60, Polyisobutene, Ceteth-10 Phosphate, Disodium EDTA, Bisabolol, PVM/MA Copolymer, Phenoxyethanol, Sodium Hydroxide, Magnesium Aluminum Silicate, Tocopheryl Acetate, Sodium Benzoate, Titanium Dioxide (CI 77891)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EMERGENCY ZIT TREATMENT ACNE
salicylic acid stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61084-125 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) STEARETH-2 (UNII: V56DFE46J5) OLETH-10 (UNII: JD797EF70J) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) OCTYLDODECANOL (UNII: 461N1O614Y) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) BAKUCHIOL (UNII: OT12HJU3AR) ALLANTOIN (UNII: 344S277G0Z) HYALURONATE SODIUM (UNII: YSE9PPT4TH) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) C18-C21 ALKANE (UNII: 33822S0M40) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) CAPRYLYL GLYCOL (UNII: 00YIU5438U) XANTHAN GUM (UNII: TTV12P4NEE) SQUALANE (UNII: GW89575KF9) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) POLYSORBATE 60 (UNII: CAL22UVI4M) POLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y) CETETH-10 PHOSPHATE (UNII: 4E05O5N49G) EDETATE DISODIUM (UNII: 7FLD91C86K) LEVOMENOL (UNII: 24WE03BX2T) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM HYDROXIDE (UNII: 55X04QC32I) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SODIUM BENZOATE (UNII: OJ245FE5EU) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61084-125-02 1 in 1 CARTON 1 NDC:61084-125-01 2 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 11/05/2013 Labeler - Basic Research (805947405) Registrant - Wasatch product Development (962452533) Establishment Name Address ID/FEI Business Operations Wasatch product Development 962452533 manufacture(61084-125)
