Original Strength Terminator

Dosage form: cream
Ingredients: Benzoyl Peroxide 5g in 100g
Labeler: University Medical Pharmaceuticals Corp
NDC Code: 50544-003

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.

Original Strength Terminator

Active Ingredient: 5.0% w/v Benzoyl Peroxide

Purpose: Acne Treatment

Use for the treatment of acne.

Warnings
For external use only.

Do not use if you are sensitive to Benzoyl Peroxide or have very sensitive skin. This product may cause irritation. If excess irritation occurs, discontinue use.

Ask a doctor or pharmacist before use if you are using any topical acne drugs at the same time or right after use of this product. This may cause irritation, characterized by redness, burning, itching, peeling or possibly swelling. Mild irritation may be reduced by using the product less frequently or in lower concentration. Ir irritation becomes severe, discontinue use. If irritation still continues, consult a doctor.

When using this product
  • avoid contact with eyes. If contact occurs, flush thoroughly with water.
  • keep away from lips and mouth
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid product contact with hair and dyed fabrics, including carpets and clothing which may be bleached by this product.

Stop use and ask a doctor if excess irritation occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions
Wash skin thoroughly and dry. Apply directly on blemishes. Apply once a day initially, then two to three times daily. If dryness or mild peeling occurs reduce application to once a day, as needed.
If using with 3-Step AcneFree 24 Hour Acne Clearing Systems: Apply 2-3 hours after Step 3. Apply a small patch test for the first application. Wait 24 hours. Ir irritation, redness or bothersome dryness does not occur, continue use 1-2 times daily. Do not use at night.

Inactive Ingredients: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzalkonium Chloride, Bisabolol, Butylene Glycol, Caprylic/Capric Triglyceride, Chamomilla Recutita (Matricaria) Flower Extract, Ethylhexylglycerin, Glycerin, Methyk Methacrylate/Glycol Dimethacrylate Crosspolymer, Methylpropanediol, Phenoxyethanol, Sea Whip Extract, Sodium Benzoate, Sodium Hydroxide, Tetrasodium EDTA, Water/Aqua, Zingiber Officinale (Ginger) Root Extract.

Original Strength Terminator
Advanced 5% Micro-Benzoyl Peroxide
ORIGINAL STRENGTH TERMINATOR 
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50544-003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (Benzoic Acid) Benzoyl Peroxide5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE A 
BENZALKONIUM CHLORIDE 
LEVOMENOL 
butylene glycol 
MEDIUM-CHAIN TRIGLYCERIDES 
CHAMOMILE 
ethylhexylglycerin 
glycerin 
methylpropanediol 
phenoxyethanol 
PSEUDOPTEROGORGIA ELISABETHAE 
sodium benzoate 
sodium hydroxide 
EDETATE SODIUM 
water 
ginger 
Packaging
#Item CodePackage Description
1NDC:50544-003-911 TUBE (TUBE) in 1 CARTON
1NDC:50544-003-0028 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D09/12/2011
Labeler - University Medical Pharmaceuticals Corp (809706252)
Registrant - University Medical Pharmaceuticals Corp (809706252)
Establishment
NameAddressID/FEIOperations
Universal Packaging Systems, INC177711082manufacture

Revised: 09/2011
 
University Medical Pharmaceuticals Corp

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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