PERIGIENE- antimicrobial drug product soap

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)

Available from:

Dermarite Industries LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic - Antiseptic cleanser for use in the perineal area.

Authorization status:

OTC monograph not final

Summary of Product characteristics

PERIGIENE- ANTIMICROBIAL DRUG PRODUCT SOAP
DERMARITE INDUSTRIES LLC
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DRUG LISTING: PERIGIENE
ACTIVE INGREDIENT
Chloroxylenol 0.5%
PURPOSE:
Antiseptic
USES:
Antiseptic cleanser for use in the perineal area.
WARNINGS:
FOR EXTERNAL USE ONLY.
AVOID CONTACT WITH EYES. In case of contact, flush thoroughly with
water.
ASK A DOCTOR BEFORE USE IF you have , deep of puncture wounds, animal
bites,
serious burns
WHEN USING THIS PRODUCT, do not apply to areas of raw or blistered
skin in large
quantities, do not use in or near the eyes
STOP USE AND ASK A DOCTOR IF, condition worsens, symptoms last for
more than 7
days or clear up and recur within a few days
WARNINGS:
KEEP OUT OF REACH OF CHILDREN. In case of accidental ingestion contact
a physician or
Poison Control Center right away
DIRECTIONS:
Apply to perineal area.
Wipe with soft cloth.
Repeat as needed to clean the area.
OTHER INFORMATION:
Store at room temperature (59°-86°F). You may report a serious
adverse event to
DermaRite Industries, PO Box 7209, North Bergen, NJ 07047
INACTIVE INGREDIENTS:
Water, Sodium Lauryl sulfate, Sodium Laureth Sulfate, cocamide MEA,
Cocamidopropyl
Betaine, Polysorbate 20, Propylene glycol, DMDM Hydantoin,
Methylparaben,
Propylparaben, Disodium EDTA, Sodium Isostearoyl Lactylate, Aloe
Barbadensis Leaf
Juice, Citrus Limon (Lemon) Peel Oil, Citric Acid, Sodium Hydroxide.
QUESTION?
Call 1-800-337-6296 Mon-Fri 9AM-5PM EST.
PERIGIENE PACKAGE LABEL PRINCIPAL DISPLAY PANEL
PERIGIENE
antimicrobial drug product soap
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:61924-198
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL -
UNII:0F32U78V2Q)
CHLOROXYLENOL
0.005 g in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5Q