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NDC 11701-0172-52 Antiseptic Solution 4 g/100mL Details
Antiseptic Solution 4 g/100mL
Antiseptic Solution is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Coloplast Corp. The primary component is CHLORHEXIDINE GLUCONATE.
Product Information
NDC | 11701-0172 |
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Product ID | 11701-172_c4e4068b-5e5f-a571-e053-2995a90a98a5 |
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 | Antiseptic Solution |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Chlorhexidine Gluconate 4% |
Product Type | HUMAN OTC DRUG |
Dosage Form | SOLUTION |
Route | TOPICAL |
Active Ingredient Strength | 4 |
Active Ingredient Units | g/100mL |
Substance Name | CHLORHEXIDINE GLUCONATE |
Labeler Name | Coloplast Corp |
Pharmaceutical Class | Decreased Cell Wall Integrity [PE] |
DEA Schedule | n/a |
Marketing Category | NDA |
Application Number | NDA019125 |
Listing Certified Through | 2024-12-31 |
Package
Package Images





NDC 11701-0172-52 (11701017252)
NDC Package Code | 11701-172-52 |
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Billing NDC | 11701017252 |
Package | 118 mL in 1 BOTTLE (11701-172-52) |
Marketing Start Date | 2021-07-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL c4e4068b-5e5e-a571-e053-2995a90a98a5 Details
Uses
- surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
- healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
- patient preoperative skin preparation: for the preparation of the patient's skin prior to surgery
- skin wound and general cleansing
Warnings
Do not use
When using this product
- keep out of the 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
- 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 advised by a health care provider
Stop use and ask a doctor if
Keep out of reach of children.
Directions
- use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns
Surgical hand scrub:
- wet hands and forearms with water
- scrub for 3 minutes with about 5 mL of product and a wet brush paying close attention to the nails, cuticles, and interdigital spaces
- a seperate nail cleaner may be used
- rinse thoroughly
- wash for an additional 3 minutes with 5 mL of 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 15 seconds
- rinse and dry thoroughly
Patient preoperative skin preparation:
- apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel
- repeat procedure for an additional 2 minutes and dry with a sterile towel
Skin wound and general skin cleansing:
- thoroughly rinse the area to be cleaned with water
- apply the minimum amount of product necessary to cover the skin or wound area and wash gently
- rinse again thoroughly
Inactive ingredients
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL
Micro-Guard® CHG Solution
NDC 11701-172-52
Chlorhexidine Gluconate 4% Solution Antiseptic
4%
CHG Solution
Antiseptic
Non-Sterile Solution
For Single Use
Manufactured for and Distributed by:
Coloplast Corp, 1601 W River Rd N, Minneapolis, MN 55411 U.S.A.
1-800-533-0464 www.coloplast.us Product #67770
©2021-05, Coloplast Corp. Micro-Guard is a registered trademark
of Coloplast A/S. Made in the U.S.A.
4 fl. oz. (118 mL)
E21-1475
4COL04BTLLBL
INGREDIENTS AND APPEARANCE
ANTISEPTIC SOLUTION
chlorhexidine gluconate 4% solution |
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Labeler - Coloplast Corp (110326675) |
Registrant - Xttrium Laboratories, Inc (007470579) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Xttrium Laboratories, Inc | 007470579 | manufacture(11701-172) |