NDC 49348-480 Antiseptic

NDC Product Code 49348-480

NDC 49348-480-62

Package Description: 1000 mL in 1 BOTTLE, PLASTIC

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Antiseptic with NDC 49348-480 is a product labeled by Mckesson. The generic name of Antiseptic is . The product's dosage form is and is administered via form.

Labeler Name: Mckesson

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • CARAMEL (UNII: T9D99G2B1R)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Mckesson
Labeler Code: 49348
Start Marketing Date: 05-19-2009 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Antiseptic Product Label Images

Antiseptic Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Tep

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Active

Eucalyptol 0.092%, Menthol 0.042%  Methyl salicylate 0.060%, Thymol 0.064%

Purtpose

Antigingivitis, Antiplaque

Use

Helps control plaque that leads to gingivitis

Warnings

For this product

Do Not Use

If you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth.  See you dentist immediately.  These may be signs of periodontitis, a serious form of gum disease

Stop Use And Ask A Dentst If

Gingivitis, bleeding, or redness persists for more than 2 weeks

Keep Out Of Reach Of Children

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallowchildren under 12 years of age - consult a dentist or doctor• this rinse is not intended to replace brushing of flossing

Other Information

Cold weather may cloud this product.  Its antiseptic properties are not affected.  Store at room temperature (57-77 F)

Inactive Ingredients

Water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

Ada Council Statement

"The ADA Council On Scientific Affairs Acceptance of Sunmark Antiseptic Mouth Rinse is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plaque above the gumline, when used as directed."

Disclaimer

This product is not manufactured or distributed by Johnson  Johnson Healthcare Products,distributor of Listerine.

Adverse Reactions

Another Quality ProductDistributed by McKessonOne Post StreetSan Francisco , CA 94104Money Back GuaranteePlease visit us at www.sunmarkbrand.com

* Please review the disclaimer below.