SPOTLESS REGIMEN FOR ACNE, BLEMISHES AND BREAKOUTS- benzoyl peroxide 
Rodan & Fields

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.

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Daily Acne Wash

Drug Facts

Active Ingredient

Benzoyl Peroxide 5%

Purpose

Acne treatment

Uses

For the treatment of acne. Helps keep skin clear of new acne blemishes, acne pimples, blackheads and whiteheads.

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.

Do not use if you

  • Have very sensitive skin.
  • Are sensitive to benzoyl peroxide.

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.

Stop and ask a doctor if

  • Skin irritation becomes severe.

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

Directions

Other Information

Store between 15-30°C (59-86°F). This product may bleach hair or dyed fabrics.

Inactive Ingredients

Water, Polyacrylamide, C13-14 Isoalkane, Jojoba Esters, Carbomer, Diethylhexyl Sodium Sulfosuccinate, Cocamidopropyl Betaine, Laureth-7, Sodium Chloride, Sodium Citrate, Sodium Hydroxide, Propanediol, Ethylhexylglycerin, Phenoxyethanol, Sodium Benzoate.

Questions? 1-888-995-5656

Acne Clearing Treatment

Drug Facts

Active Ingredient

Benzoyl Peroxide 2.5%

Purpose

Acne Treatment

Uses

For the treatment of acne. Helps keep skin clear of new acne blemishes, acne pimples, blackheads and whiteheads.

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.

Do not use if you

  • Have very sensitive skin.
  • Are sensitive to benzoyl peroxide.

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.

Stop and ask a doctor if

  • Skin irritation becomes severe.

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

Directions

Other Information

Store between 15-30°C (59-86°F). This product may bleach hair or dyed fabrics.

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? 1-888-995-5656

*When both lotion and gel are combined equally, Benzoyl Peroxide is 2.5%

Principal Display Panel - Kit Label

RODAN+FIELDS

SPOTLESS

REGIMEN FOR
ACNE, BLEMISHES
AND BREAKOUTS

DESIGNED FOR
TEENS AND YOUNG ADULTS

DEVELOPED BY STANFORD-TRAINED
DERMATOLOGISTS DR.KATIE RODAN
AND DR.KATHY FIELDS

Daily 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 - Kit Label

Principal Display Panel - Acne Clearing Treatment Tube Label

RODAN+FIELDS

SPOTLESS

ACNE
CLEARING
TREATMENT

2

Principal Display Panel - Acne Clearing Treatment Tube Label

Principal Display Panel - Daily Acne Wash Tube Label

RODAN+FIELDS

SPOTLESS

DAILY
ACNE
WASH

1

Principal Display Panel - Daily Acne Wash Tube Label
SPOTLESS REGIMEN FOR ACNE, BLEMISHES AND BREAKOUTS 
benzoyl peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14222-1600
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14222-1600-11 in 1 CARTON; Type 1: Convenience Kit of Co-Package02/13/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 125 mL
Part 21 BOTTLE, PUMP 50 mL
Part 1 of 2
SPOTLESS DAILY ACNE WASH 
benzoyl peroxide cream
Product Information
Item Code (Source)NDC:14222-1610
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14222-1610-11 in 1 CARTON
1125 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D02/13/2019
Part 2 of 2
SPOTLESS ACNE CLEARING TREATMENT 
benzoyl peroxide lotion
Product Information
Item Code (Source)NDC:14222-1620
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE0.025 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14222-1620-11 in 1 CARTON
150 mL in 1 BOTTLE, PUMP; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D02/13/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D02/13/2019
Labeler - Rodan & Fields (051659584)

Revised: 12/2020
Document Id: 8fe2204d-a8c9-4dc5-a983-1a35aee48668
Set id: 8b2c187d-4b66-4872-8243-4365ea2e8b59
Version: 5
Effective Time: 20201231
 
Rodan & Fields