SOLUTIONS SPOT-ON- benzoyl peroxide 9.48% ointment 
SGII, 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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Drug Facts

Active ingredient

Benzoyl Peroxide 9.48%

Purpose

Acne treatment

Uses

For the management of acne.

Warnings

For external use only.

Do not use

  • if you have very sensitive skin or 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.

Stop and ask a doctor if

  • bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Keep out of reach of children

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

Directions

  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 to 3 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 ingredients

Allantoin, Aloe Barbadensis (Aloe Vera) Leaf Juice, Bisabolol, C13-14 Isoparraffin, Caprylyl Glycol, Dimethyl Isosorbide, Ethylhexylglycerin, Hexylene Glycol, Laureth-7, Menthoxypropanediol, Panthenol, Phenoxyethanol, Piroctone Olamine, Polyacrylamide, Water (Aqua), Zingiber Officinale (Ginger) Root Extract.

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SOLUTIONS SPOT-ON 
benzoyl peroxide 9.48% ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72644-620
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE9.48 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BISABOLOL OXIDE B, (-)- (UNII: S32G48306Y)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
LAURETH-7 (UNII: Z95S6G8201)  
3-(L-MENTHOXY)-2-METHYLPROPANE-1,2-DIOL (UNII: 649M1Y2P72)  
PANTHENOL (UNII: WV9CM0O67Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PIROCTONE OLAMINE (UNII: A4V5C6R9FB)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
WATER (UNII: 059QF0KO0R)  
ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72644-620-1515 mg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/29/201812/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D06/29/201812/31/2020
Labeler - SGII, INC (070096792)

Revised: 1/2019
Document Id: 9b016c77-1c6b-4216-b3a7-0e93c81c2d50
Set id: 1c44c606-49f3-46dd-82c7-cfd1a114d6b9
Version: 2
Effective Time: 20190112
 
SGII, INC