THERASPEC ACNE CLEANSER- benzoyl peroxide soap 
Salient Labs, LLC

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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TheraSpec Acne Cleanser

TheraSpec
therapeutic specific cleansers
Acne Cleanser
Micronized BPO

Drug Facts Panel

Active Ingredient

Benzoyl Peroxide 5%

Acne medication

Use

for the treatment of acne

Warnings

For external use only

Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide

When using this product

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

Directions Wet face. Gently massage all over face for 20-30 seconds, avoiding eye area. Rinse thoroughly and pat dry. Recommended for use twice daily.

Inactive Ingredients Acrylates Copolymer, Allantoin, Aqua (Deionized Water), Benzyl Alcohol, Ceteareth-20, Dehydroacetic Acid, Hydrolyzed Jojoba Esters, lsopentyldiol, Jojoba Esters, Sodium Cocyl lsethionate.

TheraSpec

Acne Cleanser

Principal Display Panel

221 ml

NDC: 52205-003-00

Label

THERASPEC  ACNE CLEANSER
benzoyl peroxide soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52205-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
ALLANTOIN (UNII: 344S277G0Z)  
WATER (UNII: 059QF0KO0R)  
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
ISOPENTYLDIOL (UNII: 19NOL5474Q)  
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52205-003-00221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/18/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D04/18/2019
Labeler - Salient Labs, LLC (130977940)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source, LLC080354456manufacture(52205-003)

Revised: 11/2019
Document Id: 9776c82c-6ab8-0be4-e053-2995a90a60bd
Set id: 83e6d5d5-a626-0bdc-e053-2991aa0a6351
Version: 5
Effective Time: 20191116
 
Salient Labs, LLC