Label: CLEAN AND CLEAR DAILY SKINCARE ESSENTIALS- salicylic acid kit
- NDC Code(s): 69968-0044-9, 69968-0209-8, 69968-0589-4
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 5, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
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Warnings
For external use only.
Flammable: Keep away from fire or flame.
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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
- Inactive ingredients
- QUESTIONS?
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- WARNINGS
-
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.
- Other information
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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?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - Kit Carton
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INGREDIENTS AND APPEARANCE
CLEAN AND CLEAR DAILY SKINCARE ESSENTIALS
salicylic acid kitProduct 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) solutionProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity 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) INGR WATER (UNII: 059QF0KO0R) 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 liquidProduct Information Item Code (Source) NDC:69968-0209 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) ALCOHOL (UNII: 3K9958V90M) 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:69968-0209-8 240 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 04/30/2012 Part 3 of 3 CLEAN AND CLEAR DUAL ACTION MOISTURIZER
salicylic acid lotionProduct Information Item Code (Source) NDC:69968-0589 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) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) XANTHAN GUM (UNII: TTV12P4NEE) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0589-4 118 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 03/01/2019 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. (118772437)