SOLIMO REPAIRING TREATMENT FOR ACNE PRONE SKIN- benzoyl peroxide liquid 
Amazon.com Services LLC

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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Solimo Repairing Treatment For Acne Prone Skin

Drug Facts

Active Ingredient

Benzoyl Peroxide 2.5%

Purpose

Acne treatment gel

Uses

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

Inactive Ingredients

Water, ceteareth-20, propylene glycol, cetearyl alcohol, carbomer, ethoxydiglycol, cyclotetrasiloxane, glyceryl stearate, dimethicone, xanthan gum, peg-100 stearate, allantoin, panthenol, cyclopentasiloxane, fragrance, imidazolidinyl urea, methylparaben, propylparaben, sodium hydroxide.

Package Labeling:1oz

Label

Package Labeling:2oz

2oz

SOLIMO REPAIRING TREATMENT FOR ACNE PRONE SKIN 
benzoyl peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72288-525
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
CYCLOMETHICONE 4 (UNII: CZ227117JE)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PEG-100 STEARATE (UNII: YD01N1999R)  
ALLANTOIN (UNII: 344S277G0Z)  
PANTHENOL (UNII: WV9CM0O67Z)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
IMIDUREA (UNII: M629807ATL)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72288-525-0129 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
2NDC:72288-525-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D07/30/2020
Labeler - Amazon.com Services LLC (128990418)
Establishment
NameAddressID/FEIBusiness Operations
Filltech USA, LLC926433855manufacture(72288-525)

Revised: 6/2020
Document Id: a8aa9ded-312b-802b-e053-2995a90a3490
Set id: 19b9f227-d021-4b0e-a63d-93f3f9c3369c
Version: 1
Effective Time: 20200622
 
Amazon.com Services LLC