Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
007470579
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Xttrium Laboratories, Inc.
Xttrium Laboratories, Inc.
007470579
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acclean Chlorhexidine Gluconate 0.12% Oral Rinse
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 0404-6720-04
REF 112-6720
ACCLEAN ®
Chlorhexidine Gluconate
0.12% Oral Rinse, USP
Anti-Microbial Rinse,
Mint
DIRECTIONS FOR USE: Swish 1 tablespoon (15 ml) in mouth undiluted for 30 seconds, then**spit out.**Use after breakfast and before bedtime. Or, use as prescribed.
NOTE: To minimize medicinal taste, do not rinse with water immediately after use.
KEEP OUT OF REACH OF CHILDREN
1999HS04EZCD
by HENRY SCHEIN®
4 oz. (118 ml)
INGREDIENTS: 0.12% chlorhexidine gluconate in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No.1.
To open, press down while turning cap. To reseal, turn cap past "clicks" until tightly locked.
CAUTION, CONSULT ACCOMPANYING DOCUMENTS
Rx Only
DESCRIPTION SECTION
ACCLEAN is an oral rinse containing 0.12% chlorhexidine gluconate (1,1’-hexamethylene bis [5-(p-chlorphenyl) biguanide]di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin and FD&C Blue No. 1. Chlorhexidine gluconate product is a near neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is:
