Otc - Active Ingredient
Chlorhexidine gluconate 4% Solution
The following Structured Product Label (SPL) was submitted to the FDA by Xttrium Laboratories, Inc. for the product Antiseptic Skin Cleanser (NDC 0116-0767). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Chlorhexidine gluconate 4% Solution
Antiseptic
For external use only
Allergy alert:
This product may cause a severe allergic reaction. Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
If swallowed, get medical help or contact a Poison Control Center right away.
Surgical hand scrub:
Healthcare personnel handwash:
Skin wound and general skin cleansing:
cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol
call 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST
CVS Health
Comapre to the active ingredient in Hibiclens®
NDC 59779-767-08
Antiseptic Skin Cleanser
CHLORHEXIDINE GLUCONATE 4% SOLUTION
Antiseptic / Antimicrobial skin cleanser
For external use only
TAMPER EVIDENT: DO NOT USE IF SHRINK SEAL NECKBAND IS BROKEN OR MISSING
8 fl oz (237 mL)
4CVS08BTLLBLF
CVS Health
Comapre to the active ingredient in Hibiclens®
NDC 59779-767-08
Antiseptic Skin Cleanser
CHLORHEXIDINE GLUCONATE 4% SOLUTION
Antiseptic / Antimicrobial skin cleanser
For external use only
TAMPER EVIDENT: DO NOT USE IF SHRINK SEAL NECKBAND IS BROKEN OR MISSING
8 fl oz (237 mL)
4CVS08LBL4CAC
CVS Health
Comapre to the active ingredient in Hibiclens®
NDC 59779-767-16
Antiseptic Skin Cleanser
CHLORHEXIDINE GLUCONATE 4% SOLUTION
Antiseptic / Antimicrobial skin cleanser
For external use only
TAMPER EVIDENT: DO NOT USE IF SHRINK SEAL NECKBAND IS BROKEN OR MISSING
16 fl oz (473 mL)
4CVS16BTLLBLA
CVS Health
Comapre to the active ingredient in Hibiclens®
NDC 59779-767-16
Antiseptic Skin Cleanser
CHLORHEXIDINE GLUCONATE 4% SOLUTION
Antiseptic / Antimicrobial skin cleanser
For external use only
TAMPER EVIDENT: DO NOT USE IF SHRINK SEAL NECKBAND IS BROKEN OR MISSING
16 fl oz (473 mL)
4CVS16LBL4CAB
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