Scrub
FDA Label NDC 61037-412

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bajaj Medical, Llc for the product Scrub (NDC 61037-412). 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 active ingredient, purposes, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

chlorhexidine gluconate 0.75% solution

Purposes

Antispetic

Uses

  • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease

Warnings

For external use only.

Do Not Use

  • if you are allergic to chlorhexidine gluconate or any other ingredients
  • in contact with meninges
  • in the genital area
  • as a preoperative skin preparation (especially on the head and face)
  • on skin wonds
  • general skin cleanser as surgical hand scrub

When Using This Product

  • keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardrums.
  • if solution should contact these areas, rinse out promptly and thoroughly with water

Stop Use And Ask A Doctor If

irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Other Safety Information

This product contains a chemical known to the State of California to cause Cancer.

Directions

  • use with care in premature infants and infants under 2 months of age. These products may cause irritation or chemical burns.

    • Healthcare personnel handwash:

    • wet hands with water
    • dispense about 5 ml of product into cupped hands and wash in a vigorous manner for 30 seconds
    • rinse and dry thoroughly

Other Information

  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)

Inactive Ingredients

cocamide DEA, FD&C yellow #5, FD&C red #4, fragrance, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water, ricinoleamidopropyl trimethyl ammonium chloride

Questions Of Comments?

Call 1-855-332-2525 Monday through Friday7:00 AM to 3:30 PM

Package/Label Principal Display Panel

NDC 61037-412-01

SCRUB™

FROM HOSTIPTAL TO HOME

Antiseptic Handwash

Chlorhexidine Gluconate 0.75% Solution

FDA Approved Antiseptic Handwash

Contains: 0.75% Chlorhexidine Gluconate

Distributed by: Bajaj Medical, LLC

415 W. Pershing Rd.,

Chicago, IL 60609

FOR EXTERNAL USE ONLY

Net Contents: 4 fl oz (118 ml)

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