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NDC 62011-0237-01 Antiseptic Skin Cleanser 4 mg/100mL Details
Antiseptic Skin Cleanser 4 mg/100mL
Antiseptic Skin Cleanser is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services, LLC. The primary component is CHLORHEXIDINE GLUCONATE.
Product Information
| NDC | 62011-0237 |
|---|---|
| Product ID | 62011-0237_959a7599-24f9-6f18-e053-2995a90ae70a |
| Associated GPIs | 92100030102020 |
| GCN Sequence Number | 007254 |
| GCN Sequence Number Description | chlorhexidine gluconate LIQUID 4 % TOPICAL |
| HIC3 | Q5B |
| HIC3 Description | TOPICAL PREPARATIONS,ANTIBACTERIALS |
| GCN | 30011 |
| HICL Sequence Number | 004297 |
| HICL Sequence Number Description | CHLORHEXIDINE GLUCONATE |
| Brand/Generic | Generic |
| Proprietary Name | Antiseptic Skin Cleanser |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Chlorhexidine Gluconate 4% |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | TOPICAL |
| Active Ingredient Strength | 4 |
| Active Ingredient Units | mg/100mL |
| Substance Name | CHLORHEXIDINE GLUCONATE |
| Labeler Name | Strategic Sourcing Services, LLC |
| 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 62011-0237-01 (62011023701)
| NDC Package Code | 62011-0237-1 |
|---|---|
| Billing NDC | 62011023701 |
| Package | 237 mL in 1 BOTTLE, PLASTIC (62011-0237-1) |
| Marketing Start Date | 2014-02-20 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.02542 |
| Pricing Unit | ML |
| Effective Date | 2024-02-21 |
| NDC Description | HM ANTISEPTIC SKIN CLEANSER 4% |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1, 5, 6 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
pharmacies include
independent retail community pharmacies and chain pharmacies. The prices
are updated on a
weekly and monthly basis
Standard Product Labeling (SPL)/Prescribing Information SPL 1222a248-eddb-6aae-e054-00144ff8d46c Details
Uses
Warnings
For external use only
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 or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
- in contact with meninges
- in the genital area
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Stop use and ask a doctor if
irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
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 eardurms.
- 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 the underlying condition makes it necessary to reduce the bacterial population 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.
Surgical hand scrub:
- wet hands and forearms under running 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 separate 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 about 15 seconds
- rinse and dry thoroughly
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
Warning: This product can expose you to coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause cancer.
Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products. Rinse completely and use only non-chlorine detergents.
*This product is not manufactured or distributed by Mölnlycke Healthcare, owner of the registered trademark Hibiclens®.
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| ANTISEPTIC SKIN CLEANSER
chlorhexidine gluconate 4% liquid |
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| Labeler - Strategic Sourcing Services, LLC (116956644) |
| Registrant - Xttrium Laboratories, Inc. (007470579) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Xttrium Laboratories, Inc. | 007470579 | manufacture(62011-0237) | |
Revised: 10/2019
Document Id: 959a7599-24f9-6f18-e053-2995a90ae70a
Set id: 1222a248-eddb-6aae-e054-00144ff8d46c
Version: 5
Effective Time: 20191023