Label: SPOTLESS REGIMEN FOR ACNE, BLEMISHES AND BREAKOUTS- benzoyl peroxide kit
- NDC Code(s): 14222-1600-1, 14222-1610-1, 14222-1620-1
- Packager: Rodan & Fields
- 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 December 31, 2020
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
- Uses
-
Warnings
For external use only
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.
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 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.
-
Directions
- Wet skin with lukewarm water. Using fingertips, apply a thin, even layer and massage over entire face for 90 seconds, avoiding all contact with eyes. Rinse thoroughly and pat dry. Use once daily and increase to twice daily as tolerated. Wash hands after application to help avoid staining fabrics.
- 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
- Inactive Ingredients
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
-
Warnings
For external use only
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.
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 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.
-
Directions
- Clean the skin thoroughly before applying this product.
- Dispense 1-2 pumps and cover the entire affected area with a thin, even layer one to three times daily. Do not rinse product off face.
- 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.
- Wash hands after application to help avoid staining fabrics.
- Other Information
-
Inactive Ingredients
Water, Glycereth-18 Ethylhexanoate, Glycereth-18, Disiloxane, Glycerin, Butylene Glycol, Propanediol, Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Allantoin, Ascorbyl Palmitate, Bisabolol, Myristyl Alcohol, PCA, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Polygonum Cuspidatum Root Extract, Sodium Hyaluronate, Vaccinium Angustifolium (Blueberry) Fruit Extract, Zingiber Officinale (Ginger) Root Extract, Fragrance/Parfum, Carbomer, Methyl Methacrylate Crosspolymer, Cetyl Hydroxyethylcellulose, Hydroxyphenyl Propamidobenzoic Acid, Polyglyceryl-2 Isostearate, Polysorbate 80, Sorbitan Oleate, Xanthan Gum, Diethylhexyl Sodium Sulfosuccinate, Isohexadecane, Dimethyl Isosorbide, Tocopherol, Citric Acid, Sodium Citrate, Sodium Hydroxide, Caprylyl Glycol, Decylene Glycol, Hexylene Glycol, Pentylene Glycol, 1,2-Hexanediol, Ethylhexylglycerin, Hydroxyacetophenone, Phenoxyethanol, Citral, Citronellol, Limonene, Linalool, Mica, Tin Oxide, Titanium Dioxide, Blue 1 (Cl 42090), Ext. Violet 2 (Cl 60730), Red 33 (Cl 17200).
- QUESTIONS
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Principal Display Panel - Kit Label
RODAN+FIELDS
SPOTLESS
REGIMEN FOR
ACNE, BLEMISHES
AND BREAKOUTSDESIGNED FOR
TEENS AND YOUNG ADULTS- Eliminates acne-causing bacteria
-
Helps clear blackheads, whiteheads
and pimples -
Helps prevent new blemishes
from forming - Reduces shine
DEVELOPED BY STANFORD-TRAINED
DERMATOLOGISTS DR.KATIE RODAN
AND DR.KATHY FIELDSDaily Acne Wash
Benzoyl Peroxide Cream
125 mL/4.2 Fl. Oz. U.S.
Acne Clearing Treatment
Benzoyl Peroxide Lotion*
50 mL/1.7 Fl. Oz. U.S.
- Principal Display Panel - Acne Clearing Treatment Tube Label
- Principal Display Panel - Daily Acne Wash Tube Label
-
INGREDIENTS AND APPEARANCE
SPOTLESS REGIMEN FOR ACNE, BLEMISHES AND BREAKOUTS
benzoyl peroxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14222-1600 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14222-1600-1 1 in 1 CARTON; Type 1: Convenience Kit of Co-Package 02/13/2019 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 125 mL Part 2 1 BOTTLE, PUMP 50 mL Part 1 of 2 SPOTLESS DAILY ACNE WASH
benzoyl peroxide creamProduct Information Item Code (Source) NDC:14222-1610 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) DOCUSATE SODIUM (UNII: F05Q2T2JA0) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) LAURETH-7 (UNII: Z95S6G8201) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPANEDIOL (UNII: 5965N8W85T) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14222-1610-1 1 in 1 CARTON 1 125 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 02/13/2019 Part 2 of 2 SPOTLESS ACNE CLEARING TREATMENT
benzoyl peroxide lotionProduct Information Item Code (Source) NDC:14222-1620 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 0.025 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERETH-18 ETHYLHEXANOATE (UNII: IWS58C6V2Y) GLYCERETH-18 (UNII: SA5E43C17C) HEXAMETHYLDISILOXANE (UNII: D7M4659BPU) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PROPANEDIOL (UNII: 5965N8W85T) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) ALLANTOIN (UNII: 344S277G0Z) ASCORBYL PALMITATE (UNII: QN83US2B0N) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Ext. D&C VIOLET NO. 2 (UNII: G5UX3K0728) DECYLENE GLYCOL (UNII: S57M60MI88) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) DOCUSATE SODIUM (UNII: F05Q2T2JA0) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GINGER (UNII: C5529G5JPQ) HEXYLENE GLYCOL (UNII: KEH0A3F75J) HYALURONATE SODIUM (UNII: YSE9PPT4TH) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77) ISOHEXADECANE (UNII: 918X1OUF1E) LEVOMENOL (UNII: 24WE03BX2T) LOWBUSH BLUEBERRY (UNII: G90PX41VP0) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) MICA (UNII: V8A1AW0880) MYRISTYL ALCOHOL (UNII: V42034O9PU) PENTYLENE GLYCOL (UNII: 50C1307PZG) PHENOXYETHANOL (UNII: HIE492ZZ3T) PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q) PIDOLIC ACID (UNII: SZB83O1W42) POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC) POLYSORBATE 80 (UNII: 6OZP39ZG8H) REYNOUTRIA JAPONICA ROOT (UNII: 7TRV45YZF7) SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SODIUM HYDROXIDE (UNII: 55X04QC32I) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) STANNIC OXIDE (UNII: KM7N50LOS6) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TOCOPHEROL (UNII: R0ZB2556P8) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14222-1620-1 1 in 1 CARTON 1 50 mL in 1 BOTTLE, PUMP; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 02/13/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 02/13/2019 Labeler - Rodan & Fields (051659584)
