Label: SPOTLESS ACNE CLEARING TREATMENT- benzoyl peroxide lotion
- NDC Code(s): 14222-1620-1
- Packager: Rodan & Fields
- Category: HUMAN OTC DRUG LABEL
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
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
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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.
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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
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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
- Principal Display Panel - 50 mL Carton Label
- Principal Display Panel - 50 mL Tube Label
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INGREDIENTS AND APPEARANCE
SPOTLESS ACNE CLEARING TREATMENT
benzoyl peroxide lotionProduct Information Product Type HUMAN OTC DRUG 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 02/13/2019 1 50 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 02/13/2019 Labeler - Rodan & Fields (051659584)