Label: SCRUB, SCRUB-STAT- chlorhexidine gluconate solution
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Contains inactivated NDC Code(s)
NDC Code(s): 61037-421-01, 61037-421-02, 61037-421-03, 61037-421-04, view more61037-421-05, 61037-421-06, 61037-421-07, 61037-421-08, 61037-421-09, 61037-421-10, 61037-421-11, 61037-421-12, 61037-421-13, 61037-421-14, 61037-421-15, 61037-421-16, 61037-421-17, 61037-421-18, 61037-421-19, 61037-421-20, 61037-421-21, 61037-421-22, 61037-421-23, 61037-421-24, 61037-421-25 - Packager: Bajaj Medical, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated July 11, 2016
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Purposes
- Uses
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Warnings
For external use only
Allergy Alert
this product may cause a severe allergic reaction.
Symptoms may include:
- wheezing/difficulty breathing
- shock
- facial swelling
- hives
- rash
If an allergic reaction occurs, stop use and seek medical help right away.
Do not use
- if you are allergic to chlorhexidine gluconate or any other ingredients in this preparation
- as a patient properative skin preparation (especially on the head or face)
- in contact with meninges
- in the genital area
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 ear drums
- if contact occurs, rinse with cold water right away
- wounds which involve more than the superficial layers of the skin should not be routinely treated
- repeated general skin cleansing of large body areas should not be done except when underlying condition makes it necessary to reduce the bacterial population of the skin
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Directions
- use with care in premature infants or infants under 2 months of age. These product may cause irritation or chemical burns.
- use full strength
- do not dilute
Surgical hand scrub:
- remove jewelry
- wet hands and forearms with water and apply 5 mL of the product
- wash/scrub hands and forearms for 3 minutes paying particular attention to the nails, cuticles, and interdigital spaces
- rinse thoroughly with water
- wash for an additional 3 minutes with 5 mL of the product and rinse under running water
- dry thoroughly
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
Skin wound and general skin cleanser
- thoroughly rinse the area to be cleansed with water
- apply the minimum amount of product necessary to cover the skin or wound area and wash gently. Rinse thoroughly with water.
- rinse again thoroughly
- Other information
- Inactive ingredients
- Questions or comments?
- Representative label and principal display panel
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INGREDIENTS AND APPEARANCE
SCRUB, SCRUB-STAT
chlorhexidine gluconate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61037-421 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength COCAMINE OXIDE (UNII: QWA2IZI6FI) GLUCONOLACTONE (UNII: WQ29KQ9POT) PEG-75 LANOLIN (UNII: 09179OX7TB) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) COCO DIETHANOLAMIDE (UNII: 92005F972D) GLUCONIC ACID (UNII: R4R8J0Q44B) HYDROXYETHYL CELLULOSE (3000 CPS AT 1%) (UNII: 7Q6P4JN1QT) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) QUATERNIUM-33 (UNII: XPS4174QZJ) ISOPROPYL ALCOHOL (UNII: ND2M416302) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61037-421-01 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/22/1986 2 NDC:61037-421-02 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/22/1986 3 NDC:61037-421-03 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/22/1986 4 NDC:61037-421-04 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/22/1986 5 NDC:61037-421-05 473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 07/22/1986 6 NDC:61037-421-06 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/22/1986 7 NDC:61037-421-07 946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 07/22/1986 8 NDC:61037-421-08 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/22/1986 9 NDC:61037-421-09 237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 07/22/1986 10 NDC:61037-421-10 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/22/1986 11 NDC:61037-421-11 540 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/22/1986 12 NDC:61037-421-12 750 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 07/22/1986 13 NDC:61037-421-13 750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/22/1986 14 NDC:61037-421-14 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/22/1986 15 NDC:61037-421-15 800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/22/1986 16 NDC:61037-421-16 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/22/1986 17 NDC:61037-421-17 946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 07/22/1986 18 NDC:61037-421-18 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/22/1986 19 NDC:61037-421-19 1000 mL in 1 POUCH; Type 0: Not a Combination Product 07/22/1986 20 NDC:61037-421-20 1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/22/1986 21 NDC:61037-421-21 1250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 07/22/1986 22 NDC:61037-421-22 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/22/1986 23 NDC:61037-421-23 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/22/1986 24 NDC:61037-421-24 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/22/1986 25 NDC:61037-421-25 237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 07/22/1986 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019258 07/22/1986 Labeler - Bajaj Medical, LLC (078774921) Registrant - Bajaj Medical, LLC (078774921) Establishment Name Address ID/FEI Business Operations Bajaj Medical, LLC 078774921 analysis(61037-421) , manufacture(61037-421) , relabel(61037-421) , repack(61037-421)
