CLEAN AND CLEAR DAILY SKINCARE ESSENTIALS- salicylic acid kit

Clean and Clear Daily Skincare Essentials by

Drug Labeling and Warnings

Clean and Clear Daily Skincare Essentials by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Clean & Clear Essentials Deep Cleaning Astringent

Drug Facts

Active ingredient

Salicylic Acid 2%

Purpose

Acne medication

Use

For the treatment of acne.

Warnings

For external use only.

Flammable: Keep away from fire or flame.

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.
• If eye contact occurs, flush thoroughly with water.

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

Directions

• Cleanse skin thoroughly before applying this product.
• Moisten a cotton ball and 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

• Store at room temperature

Inactive ingredients

Water, SD Alcohol 40-B, Isoceteth-20, Fragrance, Propylene Glycol, Dimethicone Propyl PG-Betaine, Benzophenone-4, Red 4

Questions?

See graphics

SPL UNCLASSIFIED SECTION

Clean & Clear Essentials Dual Action Moisturizer

Drug Facts

Active ingredient

Salicylic Acid 0.5%

Purpose

Acne medication

Use

For the management of acne.

WARNINGS

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.
• Rinse right away with water if it gets in eyes.

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

Directions

• Cleanse 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.

Other information

• Store at room temperature

Inactive ingredients

Water, Dicaprylyl Ether, Cetearyl Alcohol, Glycerin, Neopentyl Glycol Diethylhexanoate, Dimethicone, Methyl Gluceth-20, Menthyl Lactate, Aluminum Starch Octenylsuccinate, Ceteth-10 Phospate, Dicetyl Phosphate, Steareth-20, Sodium Hydroxide, Steareth-2, Fragrance, Neopentyl Glycol Diisostearate, Hydrogenated Lecithin, Xanthan Gum, Magnesium Aluminum Silicate, Disodium EDTA, BHT

Questions?

See graphics

SPL UNCLASSIFIED SECTION

Distributed in the US by:
JOHNSON & JOHNSON
CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - Kit Carton

Clean &
Clear®

daily skincare
essentials

foaming
facial
cleanser

STEP 1; cleanse

STEP 2; tone

STEP 3; moisturize

8 FL. OZ. (240 mL)

8 FL. OZ. 240 mL)

4 FL. OZ. (118 mL)

INGREDIENTS AND APPEARANCE

CLEAN AND CLEAR DAILY SKINCARE ESSENTIALS 
salicylic acid kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0044

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0044-9	1 in 1 CARTON	09/20/2015

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PUMP	240 mL
Part 2	1 BOTTLE, PLASTIC	240 mL
Part 3	1 BOTTLE, PUMP	118 mL

Part 1 of 3

CLEAN AND CLEAR ESSENTIALS FOAMING FACIAL 
cleansing (cold creams, cleansing lotions, liquids, and pads) solution

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	TROLAMINE (UNII: 9O3K93S3TK)
INGR	MYRISTIC ACID (UNII: 0I3V7S25AW)
INGR	LAURIC ACID (UNII: 1160N9NU9U)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	METHYLPARABEN (UNII: A2I8C7HI9T)
INGR	BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
INGR	PROPYLPARABEN (UNII: Z8IX2SC1OH)
INGR	ETHYLPARABEN (UNII: 14255EXE39)
INGR	FD&C RED NO. 4 (UNII: X3W0AM1JLX)
INGR	D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		04/30/2012

Part 2 of 3

CLEAN AND CLEAR ESSENTIALS DEEP CLEANING   ASTRINGENT
salicylic acid liquid

Product Information
Item Code (Source)	NDC: 58232-6004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOCETETH-20 (UNII: O020065R7Z)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SULISOBENZONE (UNII: 1W6L629B4K)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58232-6004-1	240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	06/27/2011

Part 3 of 3

CLEAN AND CLEAR ESSENTIALS DUAL ACTION MOISTURIZER 
salicylic acid lotion

Product Information
Item Code (Source)	NDC: 58232-0059
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
STEARETH-20 (UNII: L0Q8IK9E08)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARETH-2 (UNII: V56DFE46J5)
NEOPENTYL GLYCOL DIISOSTEARATE (UNII: 4M6OQ34JWW)
XANTHAN GUM (UNII: TTV12P4NEE)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58232-0059-1	118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	06/24/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	09/20/2015

Labeler - Johnson & Johnson Consumer Inc. (002347102)