SPOTLESS REGIMEN FOR ACNE, BLEMISHES AND BREAKOUTS- benzoyl peroxide kit

SPOTLESS Regimen for Acne, Blemishes and Breakouts by

Drug Labeling and Warnings

SPOTLESS Regimen for Acne, Blemishes and Breakouts by is a Otc medication manufactured, distributed, or labeled by Rodan & Fields. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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

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

Inactive Ingredients

Water, Polyacrylamide, C13-14 Isoparaffin, 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

• 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 use 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

• 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

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

Inactive Ingredients

Water, Glycereth-18 Ethylhexanoate, Glycereth-18, Glycerin, Butylene Glycol, Vaccinium Angustifolium (Blueberry) Fruit Extract, Sodium Hyaluronate, Polygonum Cuspidatum Root Extract, Bisabolol, Allantoin, Zingiber Officinale (Ginger) Root Extract, Octenidine HCl, Fragrance, Phytosteryl/Octyldodecyl Lauroyl Glutamate, Methyl Methacrylate Crosspolymer, Myristyl Alcohol, Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Cyclopentasiloxane, Butyl Hydroxycyclohexane Carboxylate, Dimethyl Isosorbide, Carbomer, Polyglyceryl-2 Isostearate, Sorbitan Oleate, Diethylhexyl Sodium Sulfosuccinate, Cetyl Hydroxyethylcellulose, Cyclohexasiloxane, Polysorbate 80, Xanthan Gum, Hydroxyphenyl Propamidobenzoic Acid, Ascorbyl Palmitate, Tocopherol, PCA, Sodium Citrate, Citric Acid, Sodium Hydroxide, Propanediol, Pentylene Glycol, Isohexadecane, Caprylyl Glycol, 1,2-Hexanediol, Decylene Glycol, Hydroxyacetophenone, Propylene Glycol, Ethylhexylglycerin, Hexylene Glycol, Phenoxyethanol, Citral, Citronellol, Limonene, Linalool, Titanium Dioxide (CI 77891), Mica, Tin Oxide, Blue 1 (CI 42090), Red 33 (CI 17200), Violet 2 (CI 60725)

Questions

1-888-995-5656

Principal Display Panel - Kit Label

RODAN+FIELDS

SPOTLESS

REGIMEN FOR
ACNE, BLEMISHES
AND BREAKOUTS

DESIGNED FOR
TEENS AND YOUNG ADULTS

Eliminate 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 FIELDS

Daily Acne Wash

125 mL/4.2 Fl. Oz. U.S.

Acne Clearing Treatment

50 mL/1.7 Fl. Oz. U.S.

Principal Display Panel - Acne Clearing Treatment Tube Label

RODAN+FIELDS

SPOTLESS

ACNE
CLEARING
TREATMENT

2

Principal Display Panel - Daily Acne Wash Tube Label

RODAN+FIELDS

SPOTLESS

DAILY
ACNE
WASH

1

INGREDIENTS AND APPEARANCE

SPOTLESS REGIMEN FOR ACNE, BLEMISHES AND BREAKOUTS 
benzoyl peroxide kit

Product 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 0: Not a Combination Product	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 cream

Product Information
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		125 mL in 1 TUBE; 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

Part 2 of 2

SPOTLESS ACNE CLEARING TREATMENT 
benzoyl peroxide lotion

Product Information
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)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
D&C VIOLET NO. 2 (UNII: 350KA7O6HK)
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: 657L0NC5MT)
MICA (UNII: V8A1AW0880)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
OCTENIDINE HYDROCHLORIDE (UNII: U84956NU4B)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)
PIDOLIC ACID (UNII: SZB83O1W42)
POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPANEDIOL (UNII: 5965N8W85T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
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		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

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)