Swimmers Itch Guard
Eucalyptus
Resolutions Llc
Human Otc Drug
NDC 63264-102Swimmers Itch Guard also known as Eucalyptus is a human otc drug labeled by 'Resolutions Llc'. National Drug Code (NDC) number for Swimmers Itch Guard is 63264-102. This drug is available in dosage form of Oil. The names of the active, medicinal ingredients in Swimmers Itch Guard drug includes Eucalyptus Oil - 20 g/100mL . The currest status of Swimmers Itch Guard drug is Active.
Drug Information:
| Drug NDC: | 63264-102 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Swimmers Itch Guard |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Eucalyptus |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Resolutions Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Oil |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | EUCALYPTUS OIL - 20 g/100mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED HOMEOPATHIC |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 18 Feb, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 08 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | RESOLUTIONS LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0861158000003
|
| UPC stands for Universal Product Code. |
| UNII: | 2R04ONI662
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 63264-102-08 | 237 mL in 1 JAR (63264-102-08) | 18 Feb, 2022 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose skin protectant
Product Elements:
Swimmers itch guard eucalyptus eucalyptus oil eucalyptus oil medium-chain triglycerides olive oil safflower oil .alpha.-tocopherol acetate, d- avocado oil cinnamon oil
Indications and Usage:
Uses prevent swimmer's itch safe for children long lasting protection
Warnings:
Warnings topical cream - for external use only - keep out of eyes. flush thoroughly and gently with warm water for 10-15 minutes. stop use and consult physician if rash or irritation develops. consult physician before using if pregnant or nursing.
Dosage and Administration:
Directions (for children 2 years and older and adults): apply sunscreen first, especially spray-on sunscreens which contain alcohol (alcohol removes our product). before entering the water, apply swimmerâs itch guard to all uncovered skin that will be under water continuously for 5 minutes or longer. apply liberally and evenly. when coming out of the water, light toweling off is best because it minimizes removal of swimmerâs itch guard. reapply after 60 minutes of water activity, taking a shower or hot-tub, or repeated hard toweling offs. wash swimsuits separately in warm water.
Package Label Principal Display Panel:
01b lbl_2022 revised swimmersitchguard_label_2x8.5_2017_01