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NDC 11822-0116-05 Antiseptic Skin Cleanser 4 g/100mL Details
Antiseptic Skin Cleanser 4 g/100mL
Antiseptic Skin Cleanser is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Rite Aid. The primary component is CHLORHEXIDINE GLUCONATE.
Product Information
NDC | 11822-0116 |
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Product ID | 11822-0116_be5df410-f894-a68f-e053-2995a90a1858 |
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 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 | g/100mL |
Substance Name | CHLORHEXIDINE GLUCONATE |
Labeler Name | Rite Aid |
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 11822-0116-05 (11822011605)
NDC Package Code | 11822-0116-5 |
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Billing NDC | 11822011605 |
Package | 237 mL in 1 BOTTLE (11822-0116-5) |
Marketing Start Date | 2021-03-25 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL be5df410-f893-a68f-e053-2995a90a1858 Details
Uses
Warnings
Do not use
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 advised by a healthcare 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 about 15 seconds
- rinse and dry thoroughly
Skin wound and general skin cleansing:
- thoroughly rinse the area to be cleaned with water
- apply this 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
INGREDIENTS AND APPEARANCE
ANTISEPTIC SKIN CLEANSER
chlorhexidine gluconate 4% liquid |
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Labeler - Rite Aid (014578892) |
Registrant - Xttrium Laboratories, Inc. (007470579) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Xttrium Laboratories, Inc | 007470579 | manufacture(11822-0116) |
Revised: 3/2021
Document Id: be5df410-f894-a68f-e053-2995a90a1858
Set id: be5df410-f893-a68f-e053-2995a90a1858
Version: 1
Effective Time: 20210325