NDC 68466-2006 Ssssting Stop Gel

Echinacea Angustifolia, Ledum Palustre Twig, Urtica Dioica,

NDC Product Code 68466-2006

NDC 68466-2006-4

Package Description: 1 TUBE in 1 CARTON > 28 g in 1 TUBE

NDC 68466-2006-8

Package Description: 1 TUBE in 1 CARTON > 78 g in 1 TUBE

NDC Product Information

Ssssting Stop Gel with NDC 68466-2006 is a a human over the counter drug product labeled by Schwabe Mexico, S.a. De C.v.. The generic name of Ssssting Stop Gel is echinacea angustifolia, ledum palustre twig, urtica dioica, . The product's dosage form is gel and is administered via topical form.

Labeler Name: Schwabe Mexico, S.a. De C.v.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Ssssting Stop Gel 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.

  • ECHINACEA ANGUSTIFOLIA 1 [hp_X]/78g
  • LEDUM PALUSTRE TWIG 2 [hp_X]/78g
  • URTICA DIOICA 1 [hp_X]/78g

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.

  • CITRONELLA OIL (UNII: QYO8Q067D0)
  • ALCOHOL (UNII: 3K9958V90M)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • JOJOBA OIL (UNII: 724GKU717M)
  • CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • WITCH HAZEL (UNII: 101I4J0U34)

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.
  • 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: Schwabe Mexico, S.a. De C.v.
Labeler Code: 68466
Marketing Category: UNAPPROVED HOMEOPATHIC - 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: 10-19-2020 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: 12-31-2021 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.

Ssssting Stop Gel 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

ECHINACEA ANGUSTIFOLIA 1XLEDUM PALUSTRE 2XURTICAL DIOICA 1X

Inactive Ingredients

CITRONELLA OILETHYL ALCOHOLEUCALYPTUS OILJOJOBA OILPOLYACRYLIC ACID (Carbomer Homopolymer Type C)PURIFIED WATERSODIUM HYDROXIDEWITCH HAZEL DISTILLATE

Dosage & Administration

Directions:Adults and children 2 years of age and older: Apply to affected area.Repeat as needed.Children under 2 years of age: Consult a doctor.Patch test recommended on sensitive skin.

Purpose

Temporarily relieves the pain, itch, redness and swelling of minor insect bites and stings (ants, bees, mosquitos, wasps, etc).Soothes fever blisters and cold sores.

Indications & Usage

Temporarily relieves the pain, itch, redness and swelling of minor insect bites and stings (ants, bees, mosquitos, wasps, etc).Soothes fever blisters and cold sores.

Warning

For external use only.Avoid contact with eyes or broken skin.

Do Not Use

Do not use if hypersensitive to any ingredients in this product.Breast-feeding women should not apply to breast area.

Stop Use

Stop use and ask a doctor if skin irritation, rash or other allergic reaction develops, condition worsens or does not improve within 7 days.These could be signs of a serious condition.

Pregnancy Or Breast Feeding

If pregnancy or breast-feeding, consult a healthcare professional before use.

Keep Out Of Reach Of Children

Keep out of reach of children

Overdose

If swallowed, seek medical help or contact a Poison Control Center immediately.

* Please review the disclaimer below.