SOLUTIONS SPOT-ON- benzoyl peroxide 9.48% ointment

Solutions Spot-On by

Drug Labeling and Warnings

Solutions Spot-On by is a Otc medication manufactured, distributed, or labeled by SGII, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOLUTIONS SPOT-ON 
benzoyl peroxide 9.48% ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72644-620
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	9.48 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72644-620-15	15 mg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/29/2018	12/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	06/29/2018	12/31/2020

Labeler - SGII, INC (070096792)