OTC Medication Information: Controlling Cream

CONTROLLING CREAM- benzoyl peroxide cream
CA-BOTANA INTERNATIONAL

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.

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 Type HUMAN OTC DRUG Item Code (Source) NDC:35192-017
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 0.8 mg in 29.6 mg
Inactive Ingredients
Ingredient Name Strength
CINNAMON
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
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:35192-017-05 29.6 mg in 1 TUBE None
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 Operations
CA-BOTANA INTERNATIONAL 106276728 manufacture (35192-017)

Revised: 01/2021 CA-BOTANA INTERNATIONAL

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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