Pre-scrub Ii
FDA Label NDC 22884-8103

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Biomed Systems, Inc. for the product Pre-scrub Ii (NDC 22884-8103). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient

Chlorhexidine Gluconate 4% Solution

Indications & Usage

Uses

• surgical hand scrub: significantly reduces the number of micro-

organisms on the hands and forearms prior to surgery or patient care

Warnings

Error

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

• Use with care in Premature infants under 2 months of age. These

products may cause irritation or chemical burns.

• open package

• wet hands and forearms to the elbows with warm water

• clean under nails with nail pick provided. Nails should be maintained

with a 1 millimeter free edge

• wet sponge and squeeze to work up lather

• scrub thoroughly for 3 minutes. Paying particular attention to the

nails, cuticles and interdigital spaces. Use the brush side to clean the

nails, cuticles and interdigital spaces between the fingers and the

sponge side to scrub the hands and forearms

• rinse thoroughly with warm water

• scrub for an additional 3 minutes using the sponge side

• discard brush-sponge

• rinse hands and forearms thoroughly and dry with a sterile towel.

Other Safety Information

Other information

• store between 20-25°C (68-77°F)

•avoid freezing and excessive heat 40°C (104°F}

Inactive Ingredient

Inactive ingredientscocamide DEA, fragrance POFL 147, glucono-delta-lactone, isopropyl alcohol 4%, lauramine oxide, PEG-75 lanolin, purified water, USP, tridecyl alcohol

Otc - Questions

Questions? 800-424-5556 (Monday to Friday 8 AM – 5 PM)

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