Label: PERRICONE ACNE RELIEF CALMING AND SOOTHING CLAY MASK- salicylic acid lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 54111-156-50, 54111-156-51 - Packager: Bentley Laboratories, LLC
- 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 October 4, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only.Keep out of eyes. If product enters the eyes,
wash out thoroughly with warm water.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. - KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions ■ clean the skin thoroughly
before applying this product. ■ cover the
entire affected area with a thin layer morning
& evening. No rinsing is needed. Wait until
dry before applying treatment or moisturizer.
■ because excessive drying of the skin may
occur, start with one application daily, then
gradually increase to two or 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. -
INACTIVE INGREDIENT
Inactive ingredients Water/Aqua/Eau,
Glycerin, PEG-40 Hydrogenated Castor Oil,
Bentonite, Coco-Caprylate, Magnesium Aluminum
Silicate, Titanium Dioxide, Butylene Glycol,
Methyl Gluceth-20 Benzoate, Glyceryl Stearate,
Lactobacillus Ferment, Sodium Metabisulfite,
Tocopherol, Sodium Hydroxide, 1,2-Hexanediol,
Caprylyl Glycol, Polyacrylamide, Epilobium
Angustifolium Flower/Leaf/Stem Extract, C13-14
Isoparaffin, Succinic Acid, Xanthan Gum,
Lactic Acid, Allantoin, Laureth-7, Disodium
EDTA, Phenoxyethanol - QUESTIONS
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Product Label
Perricone MD
ACNE RELIEF
Calming &
Soothing
Clay Mask
Salicylic Acid Acne TreatmentLactobacillus Ferment,
Willowherb, Bentonite Clay
℮ 59 mL / 2 US fl. oz.Dist. By: NV Perricone LLC. Shepherdsville, KY
40165. Made in USA of foreign and domestic
components. Perricone MD, a THG brand THG
Beauty Limited Voyager House, M90 3DQ, UK
73 Rue Saint-Anne, 75002, Paris, FR. 651362
1 888 823 7837
perriconemd.com59 nL Carton
10 mL Packet
res
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INGREDIENTS AND APPEARANCE
PERRICONE ACNE RELIEF CALMING AND SOOTHING CLAY MASK
salicylic acid lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54111-156 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2.0 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) BENTONITE (UNII: A3N5ZCN45C) COCO-CAPRYLATE (UNII: 4828G836N6) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) METHYL GLUCETH-20 (UNII: J3QD0LD11P) BENZOIC ACID (UNII: 8SKN0B0MIM) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) LACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP) SODIUM METABISULFITE (UNII: 4VON5FNS3C) TOCOPHEROL (UNII: R0ZB2556P8) SODIUM HYDROXIDE (UNII: 55X04QC32I) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) SUCCINIC ACID (UNII: AB6MNQ6J6L) XANTHAN GUM (UNII: TTV12P4NEE) LACTIC ACID (UNII: 33X04XA5AT) ALLANTOIN (UNII: 344S277G0Z) LAURETH-7 (UNII: Z95S6G8201) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54111-156-50 1 in 1 CARTON 12/01/2021 1 59 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:54111-156-51 10 mL in 1 PACKET; Type 0: Not a Combination Product 12/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 12/01/2021 Labeler - Bentley Laboratories, LLC (068351753) Registrant - Bentley Laboratories, LLC (068351753)