Data from FDA - Curated by EPG Health - Last updated 25 January 2018

Indication(s)

INDICATIONS AND USAGE: BP 10-1 Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

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Advisory information

contraindications
CONTRAINDICATIONS: BP 10-1 Wash is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. BP 10-1 Wash is not to be used by patients with kidney disease.
Special warnings and precautions
PRECAUTIONS: General - if irritation occurs, discontinue use of the product and institute appropriate therapy. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility.
Adverse reactions
ADVERSE REACTIONS: Although rare, sodium sulfacetamide may cause local irritation.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION: Wash affected areas once or twice daily, or as directed by your physician. Avoid contact with eyes or mucous membranes. Wet skin and liberally apply to areas to be treated, massage gently into skin for 10-20 seconds working into a full lather, rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing wash off sooner or using less often.
Pregnancy and lactation
Nursing Mothers - It is not known whether sodium sulfacetamide is excreted in human milk following topical use of BP 10-1 Wash. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when BP 10-1 Wash is administered to a nursing woman.

More information

Category Value
Agency product number 70FD1KFU70
Orphan designation No
Product NDC 42192-104
Date Last Revised 05-01-2018
Type HUMAN PRESCRIPTION DRUG
RXCUI 999604
Marketing authorisation holder Acella Pharmaceuticals, LLC