Label: FOAMING CHLORHEXIDINE GLUCONATE- chlorhexidine gluconate liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 71788-016-10, 71788-016-20, 71788-016-50, 71788-016-60, view more71788-016-70, 71788-016-80 - Packager: Protect U Guard, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 12, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- Do Not Use
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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 contact occurs in any of these areas, rinse with cold water right away
do not inhale or ingest
- Keep out of reach of children
- Stop use and ask a doctor if
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Directions
use with care in premature infants under 2 months of age. These products may cause irritation or chemical burns.
skin wound and skin cleansing. Thoroughly rinse the area to be cleansed with water. Apply the minimum amount of the product necessary to cover the skin or wound area and wash gently. Rinse thoroughly
surgical hand scrub. Wet hands and forearms with water. Scrub for 3 minutes with 5mL of the product with brush. Rinse thoroughly under running water. Repeat. Dry thoroughly.
healthcare personnel handwash. Wet hands with water. Dispense 5 mL of the product into cupped hands. Wash in a vigorous manner for 15 seconds. Rinse and dry thoroughly.
- Other Information
- Inactive ingredients:
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FOAMING CHLORHEXIDINE GLUCONATE
chlorhexidine gluconate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71788-016 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 4 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) ISOPROPYL ALCOHOL (UNII: ND2M416302) GLUCONOLACTONE (UNII: WQ29KQ9POT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71788-016-80 24 in 1 CARTON 04/13/2021 1 NDC:71788-016-70 100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:71788-016-20 4 in 1 CARTON 04/13/2021 2 NDC:71788-016-10 1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 3 NDC:71788-016-60 12 in 1 CARTON 04/13/2021 3 NDC:71788-016-50 530 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part349 04/13/2021 Labeler - Protect U Guard, LLC (080070945) Establishment Name Address ID/FEI Business Operations Protect U Guard, LLC 080070945 manufacture(71788-016) , pack(71788-016) , repack(71788-016)
