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Controlling Cream

Dosage form: cream
Ingredients: BENZOYL PEROXIDE 0.8mg in 29.6mg
Labeler: CA-BOTANA INTERNATIONAL
NDC Code: 35192-017

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.

Controlling Cream

Warnings:

For external use only.
Do not use on wounds or damaged skin
When using this product: use only as directed. Avoid contact with eyes. Do no bandage tightly
Stop use and ask a doctor if: redness is present. Irritation develops. Condition worsens or symptoms persist more than 7 days. Symptoms clear up and occur again within a few days.
Store at room temperature. Lot number and expiration date see crimp or see box.

cleanse the skin thoroughly with soft foam deep cleanse before applying. cover the entire affected aread with a thin layer 1 to 2 times daily. because too much drying of the skin may occure, start with 1 application daily, then gradually increase to 2 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. Allow benzoyl peroxide to dry the follow directions on sunscreen label.

Alpha Oligo Peptide-6 TM
Calendula officinalis (Marigold) Extract
Cetearyl Alcohol
Cetearyl Isononanoate
Cynamomum Zeylanicum
Ethylhexylglycerin
Glycerine
Glycine
Hydrogen Peroxide
Mineral oil
Oenothera biennis (Evening Primrose) extract
Panicum Miliaceum (Millet)extract
Petrolatum
Phenoxyethanol
Phosphatidycholine
Polysorbate 60
Potassium Sorbate
Rosa canina (Roseship) extract
Rosmarinus officinalis (Rosemary) extract
Sorbitan Stearate
Tetra Sodium
Water (Aqua)


Keep out of reach of children. If swallowed get medical help or contact a Posion Control Center immediately.

when using this product apply to affected areas only. avoid unnecessary sun exposure and use a sunscreen. do not use in or near eyes. using other topical acne drugs at the same time or right

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Package label display panel
CONTROLLING CREAM 
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35192-017
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE0.8 mg  in 29.6 mg
Inactive Ingredients
Ingredient NameStrength
CINNAMON LEAF OIL 
ETHYLHEXYLGLYCERIN 
GLYCERIN 
GLYCINE 
HYDROGEN PEROXIDE 
LIGHT MINERAL OIL 
OENOTHERA BIENNIS 
MILLET 
PETROLATUM 
PHENOXYETHANOL 
HYDROGENATED SOYBEAN LECITHIN 
POLYSORBATE 60 
POTASSIUM SORBATE 
ROSA CANINA LEAF 
ROSEMARY 
SORBITAN MONOSTEARATE 
EDETATE SODIUM 
WATER 
CETOSTEARYL ALCOHOL 
CETEARYL ISONONANOATE 
CINNAMON 
Packaging
#Item CodePackage Description
1NDC:35192-017-0529.6 mg in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D11/09/2014
Labeler - CA-BOTANA INTERNATIONAL (106276728)
Registrant - RODOLFO UGELSTAD (106276728)
Establishment
NameAddressID/FEIOperations
CA-BOTANA INTERNATIONAL106276728manufacture(35192-017)

Revised: 11/2017
 
CA-BOTANA INTERNATIONAL

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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