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NDC 42508-0282-11 Essentials .32; 100; 50 mg/g; mg/g; mg/g Details
Essentials .32; 100; 50 mg/g; mg/g; mg/g
Essentials is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Arbonne International, LLC. The primary component is CAPSICUM OLEORESIN; METHYL SALICYLATE; RACEMENTHOL.
Product Information
NDC | 42508-0282 |
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Product ID | 42508-282_cfe4390f-08ef-4b4b-8a7c-1f779c624da9 |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Essentials |
Proprietary Name Suffix | Herbal Muscle Massage |
Non-Proprietary Name | CAPSICUM OLEORESIN, RACEMENTHOL, and METHYL SALICYLATE |
Product Type | HUMAN OTC DRUG |
Dosage Form | GEL |
Route | TOPICAL |
Active Ingredient Strength | .32; 100; 50 |
Active Ingredient Units | mg/g; mg/g; mg/g |
Substance Name | CAPSICUM OLEORESIN; METHYL SALICYLATE; RACEMENTHOL |
Labeler Name | Arbonne International, LLC |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part348 |
Listing Certified Through | 2022-12-31 |
Package
Package Images

NDC 42508-0282-11 (42508028211)
NDC Package Code | 42508-282-11 |
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Billing NDC | 42508028211 |
Package | 113 g in 1 TUBE (42508-282-11) |
Marketing Start Date | 2012-02-22 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 3b276a2b-22a0-4021-8199-e850936cbe12 Details
SPL UNCLASSIFIED SECTION
Uses
Warnings
For external use only
Allergy alert: if prone to allergic reaction from aspirin or salicylate, consult a doctor before using
When using this product
- do not get into eyes. If contact occurs, rinse eyes thoroughly with water
- do not apply to wounds or damaged skin
- do not bandage tightly
Directions
Inactive ingredients
Acrylates/C10-30 alkyl acrylate crosspolymer, aminomethyl propanol, anthemis nobilis flower extract, arnica montana flower extract, butylene glycol, calendula officinalis flower extract, disodium EDTA, eucalyptus globulus leaf oil, hamamelis virginiana (witch hazel) extract, lecithin, phenoxyethanol, water.
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 113 g Tube Label
INGREDIENTS AND APPEARANCE
ESSENTIALS
HERBAL MUSCLE MASSAGE
capsicum oleoresin, racementhol, and methyl salicylate gel |
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Labeler - Arbonne International, LLC (021541164) |
Registrant - Levlad, LLC (076245109) |
Revised: 12/2018
Document Id: cfe4390f-08ef-4b4b-8a7c-1f779c624da9
Set id: 3b276a2b-22a0-4021-8199-e850936cbe12
Version: 2
Effective Time: 20181221