BEYONDCLEAR- salicylic acid and benzoyl peroxide   
Proskin LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Chemical Structure

Benzoyl Peroxide

Benzoyl Peroxide Chemical Structure

Salicylic Acid

Salicylic Acid Chemical Structure

Active ingredient                                                                 

Benzoyl Peroxide 4.25%

Salicylic Acid (2.0%) 

Purpose

Acne medication

Uses

For the treatment of breakouts or acne

Warnings

For external use only.

Do not use if
  • you have very sensitive skin 
  • are sensitive to benzoyl peroxide

When using this product

For Pure

  • 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 unless directed by a doctor
  • Avoid contact with the eyes. If contact occurs, immediately flush with water.

For Clear 

  • skin irritation and dryness is more likely to occur if use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time
  • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor
  • avoid contact with the eyes, lips, and mouth
  • avoid contact with hair and dyed fabrics, which may be bleached by this product
  • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently, in smaller amount or in a lower concentration.

Stop use and ask a doctor if skin irritation becomes severe

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For Pure

Use in the morning and evening. Put a nickel- sized amount in hand

  • Cover the entire area of concern with a thin layer Gently massage on to wet skin. Rinse and pat dry 
  • 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.

For Clear

Use in the morning and evening after cleansing 

  • Clean the skin thoroughly before applying this product
  • Cover the entire area of concern with a thin layer two times daily. Hold can upright. Dispense a dime-sized amount of product in your hand. Gently massage into skin. No need to shake container. Store upright
  • 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
  • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

For FAST

  • Clean the skin thoroughly before applying this product. Use as needed and on-the-go
  • Apply a thin layer directly on the breakout area. Start with one application daily, and increase to two if needed. Do not rinse off
  • If bothersome dryness occurs, reduce usage
  • Sun protection is recommended by dermatologists as an essential part of any healthy skin care regimen.

Inactive Ingredients

For Pure

Purified Water, Glycerin, PEG-120 Methyl Glucose Dioleate, Cocamidopropyl Betaine, Sodium Cocoamphoacetate, PEG-200 Hydrogenated Glyceryl Palmate, Glucoside, Disodium Cocoyl Glutamate, Xylitylglucoside, Sodium Cocoyl Glutamate, Sodium Lauryl Glucose Carboxylate, Acer Saccharum (Sugar Maple) Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Saccharum Officinarum (Sugar Cane) Extract, Vaccinium Myrtillus Fruit/Leaf Extract, Anhydroxylitol, Lappa Root Extract, Citrus Limon (Lemon) Extract, Glycolic Acid, Hydroxyphenyl Propamidobenzoic Acid, Mandelic Acid, Sisymbrium Officinale Extract, Xylitol, Zinc PCA, PEG-7 Glyceryl Cocoate, Pentylene Glycol, Benzyl Alcohol, Butylene Glycol, Citric Acid, Sclerotium Gum, Fragrance, Polysorbate 20.

For Clear

Water, Hydrofluorocarbon 227ea, Glycerin, Pentylene Glycol, Emulsifying Wax, Dimethicone, Chamomilla Recutita (Matricaria) Flower Extract, Symphytum Officinale Extract, Phenoxyetha- nol, Steareth-10, C12-15 Alkyl Benzoate, Sodium Citrate, Cetearyl Alcohol, Fragrance, Disodium EDTA, BHT, Citric Acid, Aloe Barbadensis Leaf Juice.

For FAST

Purified Water, SD Alcohol 40-B, Butylene Glycol, Lactobacillus/Wasabia Japonica Root Ferment Extract, Glycerin, Polyacrylate Crosspolymer- 6, Allantoin, Bisabolol, Epilobium Fleischeri Extract, Juglans Nigra (Black Walnut) Shell Extract, Spiraea Ulmaria Extract, Hydroxyphenyl Propamidobenzoic Acid, Disodium EDTA, Pentylene Glycol, Ethylhexylglycerin, Phenoxyethanol.

Other Information Store at room temperature 59º-77ºF (15º-25ºC).

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - PURE PURIFYING CLEANSER Label

NDC 24424-248-96

CLARIFOAMTM

1 PURE
   PURIFYING
   CLEANSER

2% Salicylic Acid
Clears Acne

Professional
Skin Clearing
System

125 mL

PURE PURIFYING CLEANSER Label

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - CLEAR CLARIFYING TREATMENT Label

NDC 24424-328-50

CLARIFOAMTM

2 CLEAR
   CLARIFYING
   TREATMENT

4.25% Benzoyl Peroxide
Clears Acne

Professional
Skin Clearing
System

50g

CLEAR CLARIFYING TREATMENT Label

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - FAST SPOT CLEARING ACCELERATOR Label

NDC 24424-246-07

CLARIFOAMTM

FAST
SPOT
CLEARING
ACCELERATOR

2% Salicylic Acid
Clears Acne

Professional
Skin Clearing
System

7 mL

FAST SPOT CLEARING ACCELERATOR Label

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - BeyondClear Skin Clearing System Kit Label

NDC 24424-351-00

BeyondClearTM

Skin Clearing System

with Clarifoam TechnologyTM

BeyondClear Skin Clearing System Kit Label

BEYONDCLEAR 
salicylic acid and benzoyl peroxide kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:24424-351
Packaging
#Item CodePackage Description
1NDC:24424-351-001 in 1 BOX
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 125 mL
Part 21 CAN 50 g
Part 31 TUBE 7 mL
Part 41 BOTTLE 50 mL
Part 51 TUBE 15 mL
Part 1 of 5
PURE 
salicylic acid gel
Product Information
Item Code (Source)NDC:24424-248
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID2.232 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
COCAMIDOPROPYL BETAINE 
PEG-120 METHYL GLUCOSE DIOLEATE 
LAURYL GLUCOSIDE 
GLYCERYL PALMITATE 
DISODIUM COCOYL GLUTAMATE 
SODIUM COCOYL GLUTAMATE 
XYLITYLGLUCOSIDE 
ACER SACCHARUM BARK/SAP 
CITRUS AURANTIUM FRUIT RIND 
SUGARCANE 
VACCINIUM MYRTILLUS LEAF 
ANHYDROXYLITOL 
ARCTIUM LAPPA ROOT 
CITRUS LIMON FRUIT OIL 
GLYCOLIC ACID 
HYDROXYPHENYL PROPAMIDOBENZOIC ACID 
MANDELIC ACID 
SISYMBRIUM OFFICINALE WHOLE 
XYLITOL 
ZINC PIDOLATE 
PEG-7 GLYCERYL COCOATE 
PENTYLENE GLYCOL 
BENZYL ALCOHOL 
BUTYLENE GLYCOL 
CITRIC ACID MONOHYDRATE 
BETASIZOFIRAN 
POLYSORBATE 20 
Packaging
#Item CodePackage Description
1NDC:24424-248-96125 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/01/201209/30/2013
Part 2 of 5
CLEAR 
benzoyl peroxide aerosol, foam
Product Information
Item Code (Source)NDC:24424-328
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE4.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
APAFLURANE 
GLYCERIN 
PENTYLENE GLYCOL 
WHITE WAX 
DIMETHICONE 
CHAMOMILE 
COMFREY ROOT 
PHENOXYETHANOL 
STEARETH-10 
ALKYL (C12-15) BENZOATE 
SODIUM CITRATE 
CETOSTEARYL ALCOHOL 
EDETATE DISODIUM 
BUTYLATED HYDROXYTOLUENE 
CITRIC ACID MONOHYDRATE 
ALOE VERA LEAF 
Packaging
#Item CodePackage Description
1NDC:24424-328-5050 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/01/201209/30/2013
Part 3 of 5
FAST 
salicylic acid cream
Product Information
Item Code (Source)NDC:24424-246
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID2.014 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
BUTYLENE GLYCOL 
WASABI ROOT 
GLYCERIN 
ALLANTOIN 
LEVOMENOL 
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP 
JUGLANS NIGRA BARK 
FILIPENDULA ULMARIA ROOT 
HYDROXYPHENYL PROPAMIDOBENZOIC ACID 
EDETATE DISODIUM 
PENTYLENE GLYCOL 
ETHYLHEXYLGLYCERIN 
PHENOXYETHANOL 
Packaging
#Item CodePackage Description
1NDC:24424-246-077 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/01/201209/30/2013
Part 4 of 5
HEALTHY 
cleansing (cold creams, cleansing lotions, liquids, and pads) lotion
Product Information
Route of AdministrationTOPICALDEA Schedule    
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER 
INGRNIACINAMIDE 
INGRGLYCERIN 
INGRCETOSTEARYL ALCOHOL 
INGRISONONYL ISONONANOATE 
INGRHYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) 
INGRMEDIUM-CHAIN TRIGLYCERIDES 
INGRALLANTOIN 
INGRPANTHENOL 
INGRCAPRYLOYL GLYCINE 
INGRSARCOSINE 
INGRCINNAMON BARK OIL 
INGREPILOBIUM ANGUSTIFOLIUM FLOWERING TOP 
INGRAVENA SATIVA FLOWERING TOP 
INGRLEVOMENOL 
INGRGINGER 
INGRBLACK RASPBERRY 
INGRCRANBERRY SEED OIL 
INGRWATERMELON SEED OIL 
INGRRASPBERRY SEED OIL 
INGRSALVIA HISPANICA SEED 
INGRPUNICA GRANATUM SEED OIL 
INGRPUNICA GRANATUM ROOT BARK 
INGRRETINOL 
INGRTETRAHEXYLDECYL ASCORBATE 
INGREGG PHOSPHOLIPIDS 
INGRCERAMIDE 3 
INGRCERAMIDE 6 II 
INGRCERAMIDE 1 
INGRPHYTOSPHINGOSINE 
INGRCHOLESTEROL 
INGRCHAMOMILE 
INGRCOMFREY LEAF 
INGRSILICON DIOXIDE 
INGRPHENOXYETHANOL 
INGRETHYLHEXYLGLYCERIN 
INGRCETEARYL GLUCOSIDE 
INGRSODIUM ASCORBATE 
INGRTOCOPHEROL 
INGRVITAMIN A PALMITATE 
INGR.ALPHA.-TOCOPHEROL ACETATE, D- 
INGRASCORBYL PALMITATE 
INGRSODIUM LAUROYL LACTYLATE 
INGRCARBOMER 1342 
INGRXANTHAN GUM 
INGRGLYCERYL MONOSTEARATE 
INGRPEG-100 STEARATE 
INGRPOLYSORBATE 20 
INGREDETATE SODIUM 
Packaging
#Item CodePackage Description
150 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic06/01/201209/30/2013
Part 5 of 5
BOOST 
cleansing (cold creams, cleansing lotions, liquids, and pads) gel
Product Information
Route of AdministrationTOPICALDEA Schedule    
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER 
INGRALCOHOL 
INGRGLYCERIN 
INGRARGININE 
INGRPENTYLENE GLYCOL 
INGRGLYCOLIC ACID 
INGRMANDELIC ACID 
INGRLACTIC ACID 
INGRPANTHENOL 
INGRSALICYLIC ACID 
INGRPOLYQUATERNIUM-10 (400 CPS AT 2%) 
INGRBROMELAINS 
INGRNIACINAMIDE 
INGRPAPAIN 
INGRARTEMISIA VULGARIS ROOT 
INGRHYALURONATE SODIUM 
INGRCAMELLIA OLEIFERA LEAF 
INGRPHENOXYETHANOL 
Packaging
#Item CodePackage Description
115 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic06/01/201209/30/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/01/201209/30/2013
Labeler - Proskin LLC (969956668)
Registrant - Precision Dermatology, Inc. (056267369)
Establishment
NameAddressID/FEIBusiness Operations
Precision Dermatology, Inc.056267369MANUFACTURE(24424-351)

Revised: 10/2013
 
Proskin LLC