SPOTLESS DAILY ACNE- benzoyl peroxide gel

Spotless Daily Acne by

Drug Labeling and Warnings

Spotless Daily Acne by is a Otc medication manufactured, distributed, or labeled by Rodan plus Fields. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzoyl Peroxide 5%

Use:

  For the treatment of acne

Directions:

Wet face.  Apply to hands, lather and massage onto the face gently.   Rinse throughly after 90 seconds.   Start with one application daily, then gradually increase to two times, if needed.   If dryness or peeling occurs, reduce application to once a day or every other day.  If going outside, apply sunscreen after using this product.

Warnings:

For external use only.

When using this product skin irritation and dryness is more likel to occur if you use another topical acne medication at the same time.  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 and may be reduced by using the product less requently.   Do not use if you have very sensitive skin, or are sensitive to Benzoyl Peroxide.   Stop use and ask a doctor if irritation becomes severe.   Keep out of reach of children.   If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Use:

KEEP OUT OF REACH OF CHILDREN

Inactive Ingredients

C12-14 Isoparaffin, Cocamindopropyl Betaine, Coconut Fatty Acid, Ethylhesylglycerin, Glycerin, Jojoba Esters, Laureth-7, Phenoxyethanol, Polyacrylamide, Sodium Chloride, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPOTLESS DAILY ACNE 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-3750
Route of Administration	topical

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCONUT ACID (UNII: 40U37V505D)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
JOJOBA OIL (UNII: 724GKU717M)
LAURETH-7 (UNII: Z95S6G8201)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-3750-1	125 mL in 1 TUBE; Type 0: Not a Combination Product	12/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	12/01/2018

Labeler - Rodan plus Fields (051659584)