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NDC 00116-8500-89 Provon Antimicrobial Foam Handwash 20 mg/mL Details
Provon Antimicrobial Foam Handwash 20 mg/mL
Provon Antimicrobial Foam Handwash is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Xttrium Laboratories, Inc.. The primary component is CHLORHEXIDINE GLUCONATE.
Product Information
| NDC | 00116-8500 |
|---|---|
| Product ID | 0116-8500_973e0c34-8585-ba4d-e053-2995a90a8fb0 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Provon Antimicrobial Foam Handwash |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Chlorhexidine Gluconate 2% |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | TOPICAL |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/mL |
| Substance Name | CHLORHEXIDINE GLUCONATE |
| Labeler Name | Xttrium Laboratories, Inc. |
| Pharmaceutical Class | Decreased Cell Wall Integrity [PE] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA019422 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00116-8500-89 (00116850089)
| NDC Package Code | 0116-8500-89 |
|---|---|
| Billing NDC | 00116850089 |
| Package | 1200 mL in 1 BOTTLE, DISPENSING (0116-8500-89) |
| Marketing Start Date | 2016-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 46dd136c-d569-0450-e054-00144ff8d46c Details
Uses
Warnings
When using this product
- keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye 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
- do not use routinely if you have wounds which involve more than the superficial layers of the skin
Directions
- Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
Healthcare personnel handwash:
- wet hands with water
- dispense 5 mL of product (6 full strokes) into cupped hands and wash in a vigorous manner for 15 seconds and rinse under running water and dry thoroughly
Surgical hand scrub:
- wet hands and forearms with water
- scrub for 3 minutes with 5 mL of product (6 full stokes), with a wet brush, paying close attention to the nails, cuticles, and skin between the fingers
- a seperate nail cleaner may be used
- rinse thoroughly
- wash for an additional 3 minutes with 5 mL of product (6 full strokes) and rinse under running water and dry thoroughly
Inactive ingredients
PRINCIPAL DISPLAY PANEL
PROVON® Antimicrobial Foam Handwash
Chlorhexidine Gluconate 2% Solution - Antiseptic
GOJOADXFLBLC
8842-643-F
8842
NDC 21749-850-90
Brought to you by GOJO
PROVON ®
Antimicrobial Foam Handwash with 2% CHG
Chlorhexidine Gluconate 2% Solution - Antiseptic
42 fl oz (1250 mL)
GOJOADXBLBLB
8842-642-B
PROVON ® Antimicrobial Foam Handwash
Chlorhexidine Gluconate 2% Solution - Antiseptic
GOJOLTXFLBLC
1922-643-F
.
1922
NDC 21749-850-89
Brought to you by GOJO
PROVON ®
Antimicrobial Foam Handwash with 2% CHG
Chlorhexidine Gluconate 2% Solution - Antiseptic
40.5 fl oz (1200 mL)
GOJOLTXBLBLB
1922-642-B
INGREDIENTS AND APPEARANCE
| PROVON ANTIMICROBIAL FOAM HANDWASH
chlorhexidine gluconate 2% solution |
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| Labeler - Xttrium Laboratories, Inc. (007470579) |
| Registrant - Xttrium Laboratories, Inc. (007470579) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Xttrium Laboratories, Inc. | 007470579 | manufacture(0116-8500) | |
Revised: 11/2019
Document Id: 973e0c34-8585-ba4d-e053-2995a90a8fb0
Set id: 46dd136c-d569-0450-e054-00144ff8d46c
Version: 4
Effective Time: 20191113