spot on treatment

spot on treatment
SPL v3
SPL
SPL Set ID af7500db-4445-36f6-e053-2995a90a8754
Route
topical
Published
Effective Date 2020-09-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzoyl peroxide (10 g)
Inactive Ingredients
peg-40 stearate sorbitan monostearate dimethicone laureth-7 aloe vera leaf propanediol dimethyl isosorbide sodium citrate allantoin levomenol docusate sodium panthenol carbomer homopolymer, unspecified type sodium hydroxide water caprylyl glycol ethylhexylglycerin ginger polyacrylamide (10000 mw) c13-14 isoparaffin 3-((l-menthyl)oxy)propane-1,2-diol phenoxyethanol xanthan gum silicon dioxide hexylene glycol

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2020-09-16

Purpose

Acne Treatment

Description

Benzoyl Peroxide 10%


Medication Information

Warnings

For External Use Only

Keep Out Of Eyes

Uses

For the treatment of Acne

Purpose

Acne Treatment

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 two or three 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.

Inactive Ingredients

Allantoin, Aloe Vera (Aloe Barbadensis) Leaf Juice, Bisabolol, Caprylyl Glycol, Carbomer, C13-14 Isoalkane, Diethylhexyl Sodium Sulfosuccinate, Dimethicone, Dimethyl Isosorbide, Ethylhexylglycerin, Ginger (Zingiber Officinale) Root Extract, Hexylene Glycol, Laureth-7, Menthoxypropanediol, Panthenol, PEG-40 Stearate, Phenoxyethanol, Polyacrylamide, Propanediol, Silica, Sodium Citrate, Sodium Hydroxide, Sorbitan Stearate, Water/Aqua/Eau, Xanthan Gum.

Description

Benzoyl Peroxide 10%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if • irritation becomes severe.

Section 50567-7

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

Section 50570-1

Do not use if you • have very sensitive skin • are sensitive to benzoyl peroxide

Section 51945-4

SeneGence

Spot-On

10% Benzoyl Peroxide

Acne Treatment

SenePlex+

15mL/0.5 fl oz U.S.

Active Ingredient

Benzoyl Peroxide 10%


Structured Label Content

Warnings

For External Use Only

Keep Out Of Eyes

Uses

For the treatment of Acne

Purpose

Acne Treatment

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 two or three 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.

Inactive Ingredients

Allantoin, Aloe Vera (Aloe Barbadensis) Leaf Juice, Bisabolol, Caprylyl Glycol, Carbomer, C13-14 Isoalkane, Diethylhexyl Sodium Sulfosuccinate, Dimethicone, Dimethyl Isosorbide, Ethylhexylglycerin, Ginger (Zingiber Officinale) Root Extract, Hexylene Glycol, Laureth-7, Menthoxypropanediol, Panthenol, PEG-40 Stearate, Phenoxyethanol, Polyacrylamide, Propanediol, Silica, Sodium Citrate, Sodium Hydroxide, Sorbitan Stearate, Water/Aqua/Eau, Xanthan Gum.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if • irritation becomes severe.

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use if you • have very sensitive skin • are sensitive to benzoyl peroxide

Section 51945-4 (51945-4)

SeneGence

Spot-On

10% Benzoyl Peroxide

Acne Treatment

SenePlex+

15mL/0.5 fl oz U.S.

Active Ingredient

Benzoyl Peroxide 10%


Advanced Ingredient Data


Raw Label Data

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