Smart Release Bpo 5%

Smart Release Bpo 5%
SPL v2
SPL
SPL Set ID 8d2f3dfd-d821-dfc6-e053-2995a90a23f8
Route
TOPICAL
Published
Effective Date 2019-06-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (5 g)
Inactive Ingredients
Water Glycerin Propylene Glycol Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Peg-8/smdi Copolymer Lactobacillus Reuteri Glycolic Acid Lactic Acid Magnesium Aluminum Silicate Anhydrous Citric Acid Xanthan Gum Potassium Hydroxide Phenoxyethanol Ethylhexylglycerin Sodium Alginate Zinc Sulfate Edetate Disodium Bergamot Oil Grapefruit Oil Orange Oil Tangerine Peel

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-02-16

Description

TREATMENT OF ACNE

Purpose

TREATMENT OF ACNE


Medication Information

Purpose

TREATMENT OF ACNE

Description

TREATMENT OF ACNE

Use

FOR THE TREATMENT OF ACNE

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 or sensitivity develops.

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 1 TOPICAL ACNE MEDICATION AT A TIME.
  • AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN. AVOID CONTACT WITH THE EYES, LIPS AND MOUTH. SKIN IRRITATION MAY OCCUR, CHARACTERIZED BY REDNESS, BURNING, ITCHINH, 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 OR SENSITIVE TO BENZOYL PEROXIDE.

Section 51945-4

Warnings

FOR EXTERNAL USE ONLY.

Directions

IMPORTANT TO USE ON A CLEAN FACE. COVER THE AFFECTED AREA WITH A THIN LAYER ONE TO THREE TIMES PER DAY. BECAUSE OF EXCESSIVE DRYING OF THE SKIN MAY OCCUR, START WITH ONE APPLICATION PER DAY THEN GRADUALLY INCREASE TO TWO APPLICATIONS PER DAY, ONE MORNING AND ONE EVENING IF NEEDED, OR AS DIRECTED BY A DOCTOR. IF DRYNESS OR PEELING OCCURS, REDUCE USE TO ONCE A DAY OR ONCE EVERY OTHER DAY. IF GOING OUTSIDE, USE A SUNSCREEN. IF IRRITATION OR SENSITIVITY DEVELOPS STOP USING BOTH PRODUCTS AND ASK A DOCTOR.

Questions?

Call toll-free T 1-800-200-6365 or visit www.acneintellifillnce.com

Active Ingredient

BENZOYL PEROXIDE 5%

Other Information

Keep tightly closed.

Protect from excessive heat (40°/140° F) and protect from freezing.

Inactive Ingredients

Water (Aqua), Glycerin, Propylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-8 SMDI Copolymer, Lactobacillus Ferment, Glycolic Acid, Lactic Acid, Magnesium Aluminum Silicate, Citric Acid, Xanthan Gum, Potassium Hydroxide, Phenoxyethanol, Ethylhexylglycerin, Hydrolyzed Algin, Zinc Sulfate, Disodium EDTA, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Aurantium Dulcis (Orange) Peel Oil.Citrus Tangerina (Tangerine) Peel Oil


Structured Label Content

Use (USE)

FOR THE TREATMENT OF ACNE

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 or sensitivity develops.

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 1 TOPICAL ACNE MEDICATION AT A TIME.
  • AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN. AVOID CONTACT WITH THE EYES, LIPS AND MOUTH. SKIN IRRITATION MAY OCCUR, CHARACTERIZED BY REDNESS, BURNING, ITCHINH, 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 OR SENSITIVE TO BENZOYL PEROXIDE.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

TREATMENT OF ACNE

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY.

Directions (DIRECTIONS)

IMPORTANT TO USE ON A CLEAN FACE. COVER THE AFFECTED AREA WITH A THIN LAYER ONE TO THREE TIMES PER DAY. BECAUSE OF EXCESSIVE DRYING OF THE SKIN MAY OCCUR, START WITH ONE APPLICATION PER DAY THEN GRADUALLY INCREASE TO TWO APPLICATIONS PER DAY, ONE MORNING AND ONE EVENING IF NEEDED, OR AS DIRECTED BY A DOCTOR. IF DRYNESS OR PEELING OCCURS, REDUCE USE TO ONCE A DAY OR ONCE EVERY OTHER DAY. IF GOING OUTSIDE, USE A SUNSCREEN. IF IRRITATION OR SENSITIVITY DEVELOPS STOP USING BOTH PRODUCTS AND ASK A DOCTOR.

Questions? (QUESTIONS?)

Call toll-free T 1-800-200-6365 or visit www.acneintellifillnce.com

Active Ingredient (ACTIVE INGREDIENT)

BENZOYL PEROXIDE 5%

Other Information (OTHER INFORMATION)

Keep tightly closed.

Protect from excessive heat (40°/140° F) and protect from freezing.

Inactive Ingredients (INACTIVE INGREDIENTS)

Water (Aqua), Glycerin, Propylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-8 SMDI Copolymer, Lactobacillus Ferment, Glycolic Acid, Lactic Acid, Magnesium Aluminum Silicate, Citric Acid, Xanthan Gum, Potassium Hydroxide, Phenoxyethanol, Ethylhexylglycerin, Hydrolyzed Algin, Zinc Sulfate, Disodium EDTA, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Aurantium Dulcis (Orange) Peel Oil.Citrus Tangerina (Tangerine) Peel Oil


Advanced Ingredient Data


Raw Label Data

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