Label: SPOTLESS DAILY ACNE WASH- benzoyl peroxide cream
- NDC Code(s): 14222-1610-1
- 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.
Updated December 29, 2020
If you are a consumer or patient please visit this version.
- Active Ingredients
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.
- 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
- 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
- Principal Display Panel - 125 mL Carton Label
- Principal Display Panel - 125 mL Tube Label
INGREDIENTS AND APPEARANCE
SPOTLESS DAILY ACNE WASH
benzoyl peroxide cream
Product Information Product Type HUMAN OTC DRUG 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 02/13/2019 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 Labeler - Rodan & Fields (051659584)