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NDC 63824-0447-10 Clearasil Clear Skin Everyday Essentials Details

Clearasil Clear Skin Everyday Essentials

Clearasil Clear Skin Everyday Essentials is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is .

Product Information

NDC	63824-0447
Product ID	63824-447_0fff2edc-546f-46b5-b63b-8726fcb5d86c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Clearasil Clear Skin Everyday Essentials
Proprietary Name Suffix	n/a
Non-Proprietary Name	Salicylic Acid and Benzoyl Peroxide
Product Type	HUMAN OTC DRUG
Dosage Form	KIT
Route	n/a
Active Ingredient Strength	n/a
Active Ingredient Units	n/a
Substance Name	n/a
Labeler Name	RB Health (US) LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333D
Listing Certified Through	2022-12-31

Package

Package Images

NDC 63824-0447-10 (63824044710)

Pricing Information	N/A
NDC Package Code	63824-447-10
Billing NDC	63824044710
Package	1 KIT in 1 CARTON (63824-447-10) * 200 mL in 1 TUBE (63824-436-01) * 90 CLOTH in 1 JAR (63824-439-90) * 1 TUBE in 1 CARTON (63824-438-01) / 28 g in 1 TUBE
Marketing Start Date	2020-09-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL dffd186b-6ea1-46e7-b4ef-c17711fd97e0 Details

SPL UNCLASSIFIED SECTION

Clearasil® Stubborn Acne Control 5in1 Exfoliating Wash

Drug Facts

Active ingredient

Salicylic acid 2%

Purpose

Acne medication

Use

for the treatment of acne

Warnings

For external use only

When using this product

avoid contact with the eyes. If product gets into the eyes, rinse thoroughly with water.
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.
limit use to the face and neck

Stop use and ask a doctor if skin or eye irritation develops

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

Directions

wet face
dispense product into hands and massage gently onto face and neck, avoiding the delicate eye area
rinse thoroughly with warm water and pat dry
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

Other information

keep tightly closed
store in a cool, dry place

Inactive ingredients

water, PPG-15 stearyl ether, hydrated silica, glycerin, stearyl alcohol, cetyl betaine, distearyldimonium chloride, sodium lauryl sulfate, cetyl alcohol, alcohol denat, steareth-21, sodium chloride, behenyl alcohol, synthetic wax, steareth-2, xanthan gum, fragrance, MEK, disodium EDTA, isopropyl alcohol, BHT, lavandula stoechas extract, methylchloroisothiazolinone, helichrysum italicum extract, methylisothiazolinone, cistus monspeliensis extract, mica, ferric ferrocyanide, titanium dioxide, FD&C blue no. 1

Questions?

1-866-25-CLEAR (1-866-252-5327).

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Distributed by: RB Health (US)

Parsippany, NJ 07054-0224

Made in Brazil

SPL UNCLASSIFIED SECTION

Clearasil® Stubborn Acne Control 5in1 Daily Pads

Drug Facts

Active ingredient

Salicylic acid 1.9%

Purpose

Acne medication

Use

for the treatment of acne

Warnings

For external use only

Flammable until dry, keep away from extreme heat or open flame

When using this product

avoid contact with the eyes. If product gets into the eyes, rinse thoroughly with water.
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.
limit use to face and neck

Stop use and ask a doctor if skin or eye irritation develops

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
wipe a pad over face and neck to 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

Other information

do not flush in toilet
store in a cool, dry place but do not freeze
keep jar tightly closed

Inactive ingredients

water, alcohol denat, isoceteth-20, aloe barbadensis leaf juice, sodium hydroxide, triethanolamine, allantoin, fragrance, menthol, disodium EDTA, potassium sorbate, sodium benzoate, citric acid

Questions?

1-866-25-CLEAR (1-866-252-5327).

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Distributed by: RB Health (US)

Parsippany, NJ 07054-0224

Made in Brazil

SPL UNCLASSIFIED SECTION

Clearasil® Stubborn Acne Control 5in1 Spot Treatment Cream

Drug Facts

Active ingredient

Benzoyl peroxide 10%

Purpose

Acne medication

Use

for the treatment of acne

Warnings

For external use only

Do not use if you

have very sensitive skin
are sensitive to benzoyl peroxide

When using this product

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 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.
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.

Stop use and ask a doctor if irritation becomes severe

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 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.

Other information

keep outer box for full product information
keep tightly closed
store at 20-25°C (68-77°F)

Inactive ingredients

water, propylene glycol, aluminum hydroxide, bentonite, glyceryl stearate SE, PEG-12, isopropyl myristate, methylparaben, carbomer, potassium hydroxide, propylparaben

Questions?

1-866-25-CLEAR (1-866-252-5327).

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Distributed by: RB Health (US)

Parsippany, NJ 07054-0224

Made in Brazil

PRINCIPAL DISPLAY PANEL - Kit Carton

Clearasil®

LESS ACNE.

MORE SAVINGS!

CLEAR SKIN EVERYDAY ESSENTIALS

SALICYLIC ACID

DAILY CARE

FIGHTS

5

STUBBORN

ACNE

PROBLEMS

WASH

ACNE PADS

BENZOYL PEROXIDE

TARGETED

TREATMENT

REDUCES

PIMPLE SIZE +

EXCESS OIL

SPOT

TREATMENT

CREAM

EXFOLIATING WASH

SALICYLIC ACID ACNE TREATMENT

6.78 FL OZ

(200 ML)

DAILY PADS

SALICYLIC ACID ACNE TREATMENT

90 PADS 2.19 IN

(5.56 CM) DIA

SPOT TREATMENT CREAM

BENZOYL PEROXIDE ACNE TREATMENT

1 OZ (28 G)

INGREDIENTS AND APPEARANCE

CLEARASIL CLEAR SKIN EVERYDAY ESSENTIALS

salicylic acid and benzoyl peroxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63824-447

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63824-447-10	1 in 1 CARTON	09/01/2020

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	200 mL
Part 2	1 JAR	90
Part 3	1 TUBE	28 g

Part 1 of 3
CLEARASIL STUBBORN ACNE CONTROL 5IN1 EXFOLIATING WASH salicylic acid lotion

Product Information
Item Code (Source)	NDC:63824-436
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	2 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
PPG-15 stearyl ether (UNII: 1II18XLS1L)
hydrated silica (UNII: Y6O7T4G8P9)
glycerin (UNII: PDC6A3C0OX)
stearyl alcohol (UNII: 2KR89I4H1Y)
cetyl betaine (UNII: E945X08YA9)
distearyldimonium chloride (UNII: OM9573ZX3X)
sodium lauryl sulfate (UNII: 368GB5141J)
cetyl alcohol (UNII: 936JST6JCN)
alcohol (UNII: 3K9958V90M)
steareth-21 (UNII: 53J3F32P58)
sodium chloride (UNII: 451W47IQ8X)
docosanol (UNII: 9G1OE216XY)
steareth-2 (UNII: V56DFE46J5)
xanthan gum (UNII: TTV12P4NEE)
Methyl Ethyl Ketone (UNII: 6PT9KLV9IO)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
isopropyl alcohol (UNII: ND2M416302)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
methylchloroisothiazolinone (UNII: DEL7T5QRPN)
helichrysum italicum flower (UNII: P62Y550X24)
methylisothiazolinone (UNII: 229D0E1QFA)
mica (UNII: V8A1AW0880)
ferric ferrocyanide (UNII: TLE294X33A)
titanium dioxide (UNII: 15FIX9V2JP)
FD&C blue no. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63824-436-01	200 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333D	12/01/2017

Part 2 of 3
CLEARASIL STUBBORN ACNE CONTROL 5IN1 DAILY PADS salicylic acid cloth

Product Information
Item Code (Source)	NDC:63824-439
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	0.03 g

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
alcohol (UNII: 3K9958V90M)
isoceteth-20 (UNII: O020065R7Z)
aloe vera leaf (UNII: ZY81Z83H0X)
sodium hydroxide (UNII: 55X04QC32I)
trolamine (UNII: 9O3K93S3TK)
allantoin (UNII: 344S277G0Z)
menthol, unspecified form (UNII: L7T10EIP3A)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
potassium sorbate (UNII: 1VPU26JZZ4)
sodium benzoate (UNII: OJ245FE5EU)
citric acid monohydrate (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63824-439-90	90 in 1 JAR; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333D	12/05/2017

Part 3 of 3
CLEARASIL STUBBORN ACNE CONTROL 5IN1 SPOT TREATMENT benzoyl peroxide cream

Product Information
Item Code (Source)	NDC:63824-438
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	10 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
propylene glycol (UNII: 6DC9Q167V3)
aluminum hydroxide (UNII: 5QB0T2IUN0)
bentonite (UNII: A3N5ZCN45C)
glyceryl stearate SE (UNII: FCZ5MH785I)
Polyethylene Glycol 600 (UNII: NL4J9F21N9)
isopropyl myristate (UNII: 0RE8K4LNJS)
methylparaben (UNII: A2I8C7HI9T)
carbomer homopolymer, unspecified type (UNII: 0A5MM307FC)
potassium hydroxide (UNII: WZH3C48M4T)
propylparaben (UNII: Z8IX2SC1OH)

#	Item Code	Package Description
Packaging
1	NDC:63824-438-01	1 in 1 CARTON
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333D	12/06/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333D	09/01/2020

Labeler - RB Health (US) LLC (081049410)

Revised: 3/2021

Document Id: 0fff2edc-546f-46b5-b63b-8726fcb5d86c

Set id: dffd186b-6ea1-46e7-b4ef-c17711fd97e0

Version: 1

Effective Time: 20210304

Search by Drug Name or NDC

NDC 63824-0447-10 Clearasil Clear Skin Everyday Essentials Details

Clearasil Clear Skin Everyday Essentials

Product Information

Package

Package Images

NDC 63824-0447-10 (63824044710)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL dffd186b-6ea1-46e7-b4ef-c17711fd97e0 Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Use

Warnings

When using this product

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Use

Warnings

When using this product

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Use

Warnings

Do not use if you

When using this product

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - Kit Carton

INGREDIENTS AND APPEARANCE