NDC 54162-009 Berri-freez

NDC Product Code 54162-009

NDC 54162-009-04

Package Description: 113 g in 1 TUBE

NDC 54162-009-16

Package Description: 454 g in 1 BOTTLE, PUMP

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

NDC Product Information

Berri-freez with NDC 54162-009 is a product labeled by Geritrex Llc. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1313823 and 1363900.

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.

  • CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
  • CARBOMER 940 (UNII: 4Q93RCW27E)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • THYME (UNII: CW657OBU4N)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • WATER (UNII: 059QF0KO0R)

Product Labeler Information

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

Labeler Name: Geritrex Llc
Labeler Code: 54162
Start Marketing Date: 07-31-2015 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 - INACTIVATED, the listing data was inactivated by the FDA. 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Berri-freez 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

Drug Facts

Active Ingredient PurposeMenthol USP 4.5% Pain Relieving Gel

Uses

For the temporary relief of minor aches andpains of muscles and joints associated with simplebackache, arthritis, strains, bruises, and sprains

Directions

For adults or children 2 years of age and olderChildren under 2 years of age, consult a doctorCleanse and dry skinApply to affected area not more than 3 to 4 times dailyMay be used with wet or dry bandages in conjunction with ice packsKeep container tightly closed

Dosage & Administration

Apply to affected area not more than 3 to 4 times daily

Warnings

For External Use Only Use only as directedAvoid contact with the eyes. Do not bandage tightlyDo not apply to wounds or damaged skinDo not use with a heating padStop use and ask a doctor if condition worsens or ifsymptoms persist for more than 7 days or clear upand occur again within a few days

Inactive Ingredients

Camphor, Carbomer 940, FD&C Blue#1, FD&C Yellow#5DMDM Hydantoin, Glycerine, I.paraguariensis Extract, Isopropyl AlcoholMethyl & Propyle paraben, Silicon Dioxide, Thyme, Triethanolamine, water

Storage And Handling

Keep away from heat and open flameStore at room temperature 15°-30°C (59°-86°F)

Otc - Keep Out Of Reach Of Children

Keep out of reach of children if swallowed, get medicalattention or contact the poison control center immediately

* Please review the disclaimer below.