Label: SCRUB- chlorhexidine gluconate solution
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Contains inactivated NDC Code(s)
NDC Code(s): 61037-412-01, 61037-412-02, 61037-412-03, 61037-412-04, view more61037-412-05, 61037-412-06, 61037-412-07, 61037-412-10, 61037-412-11 - Packager: Bajaj Medical, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 26, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purposes
- Uses
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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.
- Directions
- Other information
- Inactive ingredients
- Questions of Comments?
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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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INGREDIENTS AND APPEARANCE
SCRUB
chlorhexidine gluconate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61037-412 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE .75 mg in 100 mL Inactive Ingredients Ingredient Name Strength COCO DIETHANOLAMIDE (UNII: 92005F972D) HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5) ISOPROPYL ALCOHOL (UNII: ND2M416302) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) RICINOLEAMIDOPROPYLTRIMONIUM CHLORIDE (UNII: 93OU7D1C3U) WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 4 (UNII: X3W0AM1JLX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61037-412-01 118 mL in 1 BOTTLE, PLASTIC 2 NDC:61037-412-02 237 mL in 1 BOTTLE, PLASTIC 3 NDC:61037-412-03 473 mL in 1 BOTTLE, PLASTIC 4 NDC:61037-412-04 946 mL in 1 BOTTLE, PLASTIC 5 NDC:61037-412-05 3785 mL in 1 JUG 6 NDC:61037-412-06 237 mL in 1 BOTTLE, PUMP 7 NDC:61037-412-07 237 mL in 1 BOTTLE, PUMP 8 NDC:61037-412-10 60 mL in 1 BOTTLE, PUMP 9 NDC:61037-412-11 60 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020111 09/30/2014 Labeler - Bajaj Medical, LLC (078774921) Registrant - Bajaj Medical, LLC (078774921) Establishment Name Address ID/FEI Business Operations Bajaj Medical, LLC 078774921 manufacture(61037-412)