SOLIMO RENEWING CLEANSER FOR ACNE PRONE SKIN- benzoyl peroxide liquid

Solimo Renewing Cleanser For Acne Prone Skin by

Drug Labeling and Warnings

Solimo Renewing Cleanser For Acne Prone Skin by is a Otc medication manufactured, distributed, or labeled by Amazon.com Services LLC, Filltech USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Benzoyl Peroxide 2.5%

Purpose

Acne treatment gel

Uses

• for the management of acne

Warnings

For external use only.

When using this product:

• do not use this product more than three times per day.
• skin irritation and dryness are 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.
• 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.

Do not use

if you

• have very sensitive skin
• 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.

Directions

• Apply product sparinglyto one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below. Sensitivity Test for a New User:
• apply a small amount to dampened skin.
• cover the entire affected area with a thin layer and rinse thoroughly one to three times daily.
• 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.

Inactive Ingredients

water, cetyl esters, sorbitol, propylene glycol, polyethylene, dimethyl isosorbide, magnesium aluminum silicate, tridecyl trimellitate, glyceryl stearate, xanthan gum, peg-100 stearate, disodium peg-12 dimethicone sulfosuccinate, tridecyl stearate, neopentylglycol dicaprylate/dicaprate, sodium pca, imidazolidinyl urea, fragrance, methylparaben, propylparaben, carthamus tinctorius (safflower) seed oil, sodium hyaluronate, chamomilla recutita (matricaria) flower extract.

Package Labeling: 2oz

Package Labeling: 4oz

INGREDIENTS AND APPEARANCE

SOLIMO RENEWING CLEANSER FOR ACNE PRONE SKIN 
benzoyl peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72288-526
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETYL ESTERS WAX (UNII: D072FFP9GU)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
XANTHAN GUM (UNII: TTV12P4NEE)
PEG-100 STEARATE (UNII: YD01N1999R)
TRIDECYL STEARATE (UNII: A8OE252M6L)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
IMIDUREA (UNII: M629807ATL)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SAFFLOWER OIL (UNII: 65UEH262IS)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CHAMOMILE (UNII: FGL3685T2X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72288-526-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2020
2	NDC: 72288-526-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	07/30/2020

Labeler - Amazon.com Services LLC (128990418)

Establishment
Name	Address	ID/FEI	Business Operations
Filltech USA, LLC		926433855	manufacture(72288-526)