CA22 BENZOYL PEROXIDE CLEANSING- benzoyl peroxide gel 
Curology 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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CA22 Benzoyl Peroxide Cleansing Gel 2.5%

Drug Facts

Active Ingredient

Benzoyl Peroxide 2.5%

Purpose

Acne treatment

Uses

For the treatment of acne

Warnings

For external use only

Do not use if you

have very sensitive skin

are sensitive to benzoyl peroxide

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 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 irritation may occur, characterized 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.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Dampen skin and massage a thin layer onto the entire affected area and rinse thoroughly one to two times daily.

Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two 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.

Other Information

Store at 20°-25° (68°-77°F)

Inactive Ingredients

Water, C12-14 Alkyl Olefin Sulfonate, Glycerin, Propylene Glycol, Disodium Cocoamphodiacetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hyaluronate, Sodium Hydroxide, Phenoxyethanol, Disodium EDTA, Allantoin, Panthenol, Ethylhexylglycerin

Questions?

858-859-1188

PRINCIPAL DISPLAY PANEL - 80 ml Tube Box

Curology

Acne Cleanser

Gentle clearing face wash
2.5% benzoyl peroxide treatment

DERMATOLOGIST
FOUNDED•DEVELOPED•TESTED

80 ml / 2.7 fl oz

PRINCIPAL DISPLAY PANEL - 80 ml Tube Box
CA22 BENZOYL PEROXIDE CLEANSING 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82575-122
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
SODIUM C12-14 OLEFIN SULFONATE (UNII: 7I962MCQ71)  
Glycerin (UNII: PDC6A3C0OX)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Disodium Cocoamphodiacetate (UNII: 18L9G3U51M)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Hyaluronate Sodium (UNII: YSE9PPT4TH)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
Allantoin (UNII: 344S277G0Z)  
Panthenol (UNII: WV9CM0O67Z)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82575-122-041 in 1 BOX12/01/2022
140 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:82575-122-081 in 1 BOX12/01/2022
280 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:82575-122-151 in 1 BOX12/01/2022
3150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D12/01/2022
Labeler - Curology Inc. (104103284)
Registrant - Pharmco Laboratories, Inc. (096270814)
Establishment
NameAddressID/FEIBusiness Operations
Pharmco Laboratories, Inc.096270814MANUFACTURE(82575-122) , LABEL(82575-122) , PACK(82575-122) , ANALYSIS(82575-122)

Revised: 12/2022
Document Id: 5ee3294b-4300-440d-a889-87e1dcd7e9d3
Set id: 2bde5068-df8c-4c53-8cfe-bab5237c16b5
Version: 1
Effective Time: 20221208
 
Curology Inc.