Label: SPOTLESS ACNE CLEARING TREATMENT- benzoyl peroxide lotion
- NDC Code(s): 14222-1620-1
- Packager: Rodan & Fields
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 10, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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
- Principal Display Panel - 50 mL Carton Label
- Principal Display Panel - 50 mL Tube Label
-
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 Drug M006 02/13/2019 Labeler - Rodan & Fields (051659584)
