NDC 76348-480 Natural Relief 1222

Bryonia 6x, Rhus Toxicodendron 6x

NDC Product Code 76348-480

NDC 76348-480-32

Package Description: 896 g in 1 BOTTLE, PUMP

NDC Product Information

Natural Relief 1222 with NDC 76348-480 is a a human over the counter drug product labeled by Renu Laboratories, Inc.. The generic name of Natural Relief 1222 is bryonia 6x, rhus toxicodendron 6x. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Renu Laboratories, Inc.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Natural Relief 1222 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.

  • TOXICODENDRON PUBESCENS LEAF 2.24 g/224g
  • BRYONIA ALBA ROOT 2.24 g/224g

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.

  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
  • SQUALANE (UNII: GW89575KF9)
  • WHITE WAX (UNII: 7G1J5DA97F)
  • WATER (UNII: 059QF0KO0R)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW) (UNII: ZR28QKN0WT)
  • MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)
  • MENTHOL (UNII: L7T10EIP3A)
  • ALMOND OIL (UNII: 66YXD4DKO9)
  • SOYBEAN OIL (UNII: 241ATL177A)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • DEHYDROACETIC ACID (UNII: 2KAG279R6R)
  • GARLIC (UNII: V1V998DC17)

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: Renu Laboratories, Inc.
Labeler Code: 76348
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: 02-20-2020 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.

Natural Relief 1222 Product Label Images

Natural Relief 1222 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

Otc - Active Ingredient

Bryonia 6x HPUS 1%Rhus Toxicodendron 6x HPUS 1%

Warnings

For external use only Avoid contact with eyes and open wounds. Stop use and ask a doctor if condition persists for more than 3 days or worsens.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not use this product if you are hypersensitive to any of the ingredients.

Otc - Stop Use

Stop use and ask a doctor if condition persists for more than 3 days or worsens.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Otc - Purpose

Muscle aches and stiffnessJoint pain and muscle stiffness

Indications & Usage

Temporry relief of minor pain and stiffness of muscles and joints.

Dosage & Administration

DirectionsApply a small amount of Natural Relief 1222 to affected areas and massage into skin. Use first thing in the morning, before bed, and whenever aches and stiffness flare up.

Other Safety Information

Store at 68 ° to 77° F.

Statement Of Identity

Natural Relief 1222 HOMEOPATHIC JOINT & MUSCLE PAIN RELIEF

Inactive Ingredient

Water, Cetearyl Alcohol, Ceteareth-20, Squalene, Propylene Glycol, Prunus Amygdalus Dulcis Oil, Glycine Soja Oil, Stearic Acid, Tocopherol, Aloe Barbadensis Leaf Juice, SD Alcohol 40-B, Myristyl Myristate, Hydrolyzed Elastin, Hydrolyzed Keratin,Allium Sativum Bulb Extract, Fragrance, Triethanolamine, Menthol USP, Phenoxyethanol, Benzoic Acid, Dehydroacetic Acid

* Please review the disclaimer below.