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NDC 00363-1061-08 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 Walgreen Co.. The primary component is CHLORHEXIDINE GLUCONATE.
Product Information
| NDC | 00363-1061 |
|---|---|
| Product ID | 0363-1061_b8a57f84-d80b-23bb-e053-2a95a90adbbb |
| 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 | Walgreen Co. |
| 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 00363-1061-08 (00363106108)
| NDC Package Code | 0363-1061-08 |
|---|---|
| Billing NDC | 00363106108 |
| Package | 237 mL in 1 BOTTLE, PLASTIC (0363-1061-08) |
| Marketing Start Date | 2011-05-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 12aff7f5-c41e-5760-e054-00144ff8d46c Details
Uses
Warnings
For external use only
Allergy alert:
This product may cause a severe allergic reaction. Sypmtoms 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 of the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
- in contact with meninges
- in the genital area
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
- 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
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 normal 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
Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine-releasing products, such as chlorine bleach. Rinse completely and use only non-chlorine detergents.
WARNING: This product contains a chemical (cocamide DEA) known to the State of California to cause cancer.
‡Walgreens Pharmacist Survey Study, November 2014
‡‡This product is not manufactured or distributed by Mölnlycke Healthcare, owner of the registered trademark Hibiclens®.
Distributed by: Walgreen Co.
200 Wilmot RD., Deerfield, IL 60015
100% Satisfaction Guaranteed
walgreens.com
©2015 Walgreen Co. Made in USA
Package label and principal display panel
Well at Walgreens
NDC 0363-1061-08
Walgreens Pharmacist Recommended‡
Antiseptic Skin Cleanser
Chlorhexidine Gluconate 4% Solution/Antiseptic/Antimicrobial Skin Cleanser
Compare to the active ingredient in Hibiclens®‡‡
8 FL OZ. (237 mL)
TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING.
4WA08BTLLBLF
Well at Walgreens
NDC 0363-1061-16
Walgreens Pharmacist Recommended‡
Antiseptic Skin Cleanser
Chlorhexidine Gluconate 4% Solution/Antiseptic/Antimicrobial Skin Cleanser
Compare to the active ingredient in Hibiclens®‡‡
16 FL OZ. (473 mL)
TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING.
4WA16BTLLBLC
Walgreens
Dye-Free Antiseptic
Foaming Skin Cleanser
CHLORHEXIDINE GLUCONATE 4% SOLUTION /
ANTISEPTIC / ANTIMICROBIAL SKIN CLEANSER
Compare to Hibiclens® active ingredient
NDC 0363-1061-18
DYE FREE
Surgical hand scrub
Healthcare personnel handwash
Skin wound & general skin cleansing
18 FL OZ (532 mL)
4WA18FM1061LBL
Carton
Lidstock
Packet
INGREDIENTS AND APPEARANCE
| ANTISEPTIC SKIN CLEANSER
chlorhexidine gluconate 4% liquid |
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| Labeler - Walgreen Co. (008965063) |
| Registrant - Xttrium Laboratories, Inc. (007470579) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Xttrium Laboratories, Inc. | 007470579 | manufacture(0363-1061) | |