CONTROLLING CREAM- benzoyl peroxide cream 
CA-BOTANA INTERNATIONAL

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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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE0.8 mg  in 29.6 mg
Inactive Ingredients
Ingredient NameStrength
CINNAMON (UNII: 5S29HWU6QB)  
CINNAMON LEAF OIL (UNII: S92U8SQ71V)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCINE (UNII: TE7660XO1C)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
OENOTHERA BIENNIS (UNII: 76UI55V071)  
MILLET (UNII: TJR6B3R47P)  
PETROLATUM (UNII: 4T6H12BN9U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
ROSA CANINA LEAF (UNII: J3N2Z889QP)  
ROSEMARY (UNII: IJ67X351P9)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
EDETATE SODIUM (UNII: MP1J8420LU)  
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35192-017-0529.6 mg in 1 TUBE; Type 0: Not a Combination Product11/02/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00611/09/2014
Labeler - CA-BOTANA INTERNATIONAL (106276728)
Registrant - RODOLFO UGELSTAD (106276728)
Establishment
NameAddressID/FEIBusiness Operations
CA-BOTANA INTERNATIONAL106276728manufacture(35192-017)

Revised: 10/2023
Document Id: 07a1ca7d-3400-04ce-e063-6394a90afbcd
Set id: 6f4d2f35-1124-4d3f-b2a4-fca222c67149
Version: 12
Effective Time: 20231013
 
CA-BOTANA INTERNATIONAL