CONTROLLING CREAM- benzoyl peroxide cream

Controlling Cream by

Drug Labeling and Warnings

Controlling Cream by is a Otc medication manufactured, distributed, or labeled by CA-BOTANA INTERNATIONAL, RODOLFO UGELSTAD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

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.

DOSAGE & ADMINISTRATION

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.

INACTIVE INGREDIENT

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)

ACTIVE INGREDIENT

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

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

PURPOSE

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PRINCIPAL DISPLAY PANEL

Package label display panel

INGREDIENTS AND APPEARANCE

CONTROLLING CREAM 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35192-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	0.8 mg  in 29.6 mg

Inactive Ingredients
Ingredient Name	Strength
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)
CINNAMON (UNII: 5S29HWU6QB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35192-017-05	29.6 mg in 1 TUBE; Type 0: Not a Combination Product	11/02/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	11/09/2014

Labeler - CA-BOTANA INTERNATIONAL (106276728)

Registrant - RODOLFO UGELSTAD (106276728)

Establishment
Name	Address	ID/FEI	Business Operations
CA-BOTANA INTERNATIONAL		106276728	manufacture(35192-017)