SUPERSONIC SCRUB- benzoyl peroxide cream 
CoValence, 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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Supersonic Scrub with 5% BPO Drug Facts Label

Active Ingredients(s)

Benzoyl Peroxide 5%

Ingredients

Aqua (Water), Glycerin, Bambusa Arundinacea (Bamboo) Stem Extract, Caprylic/Capric Triglyceride, Stearic Acid, Glyceryl Stearate, Squalane, Cetearyl Alcohol, Glycerin*, Cetyl Alcohol, Citric Acid, Olea Europaea (Olive) Fruit Oil*, Alcohol, Hamamelis Virginiana (Witch Hazel) Water, Lonicera Caprifolium (Honeysuckle) Flower Extract, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Chrysanthemum Parthenium (Feverfew) Extract, Camellia Sinensis (White Tea) Leaf Extract, Citrus Aurantium Dulcis (Orange) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Retinyl Palmitate, Citrus Grandis (Pink Grapefruit) Peel Oil, Potassium Sorbate, Citrus Aurantium Dulcis (Orange) Peel Oil*, Helianthus Annuus (Sunflower) Seed Oil, Allantoin, Phytic Acid, Aloe Barbadensis Leaf Juice Powder*, Tocotrienols, Elaeis Guineensis (Palm) Oil
*Certified Organic Ingredient

Purpose

Acne Scrub

Use

Anti-bacterial scrub for the treatment of acne and acne prone skin.

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

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

When using this product

  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with the eyes, lips, and mouth
  • avoid contact with hair and dyed fabrics, which may be bleached by this product
  • skin irriation may occur, charaterized by redness, burning, itching, peeling, or possibly swelling.  Irritation may be reduced by using the product less frequently or in a lower concentration
  • stop use and ask a doctor if irritation becomes severe

Keep out of reach of children.

Directions

  • Clean the skin thoroughly before applying this product.
  • When using t this product apply only to areas with acne.
  • If going outside, apply sunscreen after using this product.  If irritation or sensitivity develops, stop use of both products and ask a doctor.

Bulk Label

label

SUPERSONIC SCRUB 
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66915-250
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE0.05 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
BAMBUSA ARUNDINACEA STEM (UNII: NRA4497HC5)  
CAPRYLIC/CAPRIC ACID (UNII: DI775RT244)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
SQUALANE (UNII: GW89575KF9)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)  
ALCOHOL (UNII: 3K9958V90M)  
HAMAMELIS VIRGINIANA LEAF WATER (UNII: 8FP93ED6H2)  
ALMOND OIL (UNII: 66YXD4DKO9)  
FEVERFEW (UNII: Z64FK7P217)  
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
CITRUS AURANTIUM FLOWER (UNII: O730ZX2Z83)  
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
GRAPEFRUIT PEEL (UNII: 3582N05Q44)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
ORANGE PEEL (UNII: TI9T76XD44)  
HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)  
ALLANTOIN (UNII: 344S277G0Z)  
PHYTIC ACID (UNII: 7IGF0S7R8I)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
TOCOTRIENOLS (UNII: KP2MW85SSQ)  
ELAEIS GUINEENSIS WHOLE (UNII: UEG2DV5C8N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66915-250-01200000 g in 1 DRUM; Type 0: Not a Combination Product05/21/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D05/21/2013
Labeler - CoValence, Inc. (070653204)
Registrant - CoValence, Inc. (070653204)
Establishment
NameAddressID/FEIBusiness Operations
CoValence, Inc.070653204manufacture(66915-250)

Revised: 4/2015
 
CoValence, Inc.