NDC 72456-002 Prevasil Ultra Care Lip Balm

Camphor,thymol

NDC Product Code 72456-002

NDC Product Information

Prevasil Ultra Care Lip Balm with NDC 72456-002 is a a human over the counter drug product labeled by Bolm, Inc.. The generic name of Prevasil Ultra Care Lip Balm is camphor,thymol. The product's dosage form is stick and is administered via topical form.

Labeler Name: Bolm, Inc.

Dosage Form: Stick - A dosage form prepared in a relatively long and slender often cylindrical form.

Product Type: Human Otc Drug 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.

Prevasil Ultra Care Lip Balm Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CAMPHOR (SYNTHETIC) 31 mg/g
  • THYMOL 1.3 mg/g

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.

  • CHAMOMILE (UNII: FGL3685T2X)
  • ACHILLEA MILLEFOLIUM OIL (UNII: 97P5D0WG43)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • CANDELILLA WAX (UNII: WL0328HX19)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • FRANKINCENSE OIL (UNII: 67ZYA5T02K)
  • HELICHRYSUM ITALICUM FLOWER OIL (UNII: O97ZV7726K)
  • JOJOBA OIL (UNII: 724GKU717M)
  • BACKHOUSIA CITRIODORA LEAF OIL (UNII: 2UQQ0PI06P)
  • LEMON OIL (UNII: I9GRO824LL)
  • EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)
  • LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)
  • MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
  • MELISSA OFFICINALIS LEAF OIL (UNII: PTP6R7263M)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)
  • RASPBERRY SEED OIL (UNII: 9S8867952A)
  • ROSA MOSCHATA OIL (UNII: J99W255AWF)
  • ROSEMARY (UNII: IJ67X351P9)
  • SAGE OIL (UNII: U27K0H1H2O)
  • HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • THYME OIL (UNII: 2UK410MY6B)
  • TOCOPHEROL (UNII: R0ZB2556P8)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Bolm, Inc.
Labeler Code: 72456
FDA Application Number: part348 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-01-2019 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: 12-31-2020 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: N 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.

Prevasil Ultra Care Lip Balm Product Label Images

Prevasil Ultra Care Lip Balm 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

Active Ingredients

Camphor- 3.10% Thymol 0.13%

Purpose

External Analgesic

Warnings

For external use onlyDo not use if you are allergic or sensitive to any ingredient in this productWhen using this product• apply only to the affected areas• do not use in or near the eyes• avoid applying directly inside the mouth• do not share this product with anyone, as this may spread infection

Uses

• helps treat and provide temporary relief from symptoms of cold sores/fever blisters• temporarily protects and helps relieve chapped or cracked lips

Stop Use And Ask A Doctor

Stop use and ask a doctor if condition worsens or does not improve within 7 days

Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a PoisonControl Center right away. CHOKING HAZARD. Has removable cap.

Directions

• for cracking or dryness, continue to cover lips until absorbed• use daily on the lips as needed during periods of high stress, sickness or fatigue, or apply liberally to the affected area within the first hour of an emerging cold sore• rub in gently but completely• for cold sores/fever blisters, reapply liberally as the cooling effect wears off and continue reapplying throughout the following 8 hours, or until symptoms subside

Storage

  • Keep away from heat. Do not freeze. Store at room temperature 20o-25oC (68o-77oF)

Inactive Ingredients

Blue Chamomile Extract*, Blue Yarrow Oil*, Calendula Extract, Candelilla Wax,Coconut Oil*, Frankincense Oil*, Helichrysum Oil*, Jojoba Oil*, Lemon Myrtle Oil,Lemon Oil*, Lemongrass Oil*, Lysine HCl, Mango Butter*, Melissa (Lemon balm)Oil*, Peppermint Oil*, Pomegranate Oil*, Raspberry Seed Oil, Rosehip Oil*,Rosemary Leaf Extract*, Sage Oil*, Sea Buckthorn Oil*, Shea Butter*, SunflowerSeed Oil*, Thyme Oil, Tocopherol (Non-GMO) *CERTIFIED ORGANIC

* Please review the disclaimer below.

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