TRUE ESSENTIALS PAIN RELIEF ROLL ON- camphor, menthol, and methyl salicylate gel

True Essentials by

Drug Labeling and Warnings

True Essentials by is a Otc medication manufactured, distributed, or labeled by Fortune Hi-Tech Marketing, Inc, Creations Garden Natural Products, Inc. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Camphor 4%
Menthol 10%
Methyl Salicylate 30%

Purpose

.……..…….............….. Topical Analgesic

...……......……….....… Topical Analgesic

.......….......… Topical Analgesic

Uses

Temporarily relieves the minor aches and  pains of muscles and joints  associated with:

• arthritis
• strains
• bruises
• sprains
• backache
  

Warnings

For external use only.

Do not use:

• on wounds or damaged skin
• with a heating pad
  
• on a child under 12 years of age with arthritis like conditions

Keep out of reach of children

In case of accidental ingestion, seek medical assistance or contact a Poison Control Center immediately.

Directions

■ Use only as directed
■ Adults and children 12 years of age and older apply
to affected area not more than 3 to 4 times daily
■ Children under 12 years of age ask a doctor

INACTIVE INGREDIENT

Water, Hydroxyethyl Cellulose, Edetate Disodium, Glyceryl Stearate Se,  Sorbitan Stearate, Stearic Acid,  Polysorbate 80, Potassium Hydroxide,  Phenoxyethanol (and) Caprylyl Glycol (and) Ethylhexylglycerin (and) Hexylene Glycol

Questions?

Call 1-859-422-7048

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

TRUE ESSENTIALS  PAIN RELIEF ROLL ON
camphor, menthol, and methyl salicylate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24488-024
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	2.96 mL  in 74 mL
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	7.4 mL  in 74 mL
Methyl Salicylate (UNII: LAV5U5022Y) (Methyl Salicylate - UNII:LAV5U5022Y)	Methyl Salicylate	22.2 mL  in 74 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
HYDROXYETHYL CELLULOSE (4000 MPA.S FOR 1% AQUEOUS SOLUTION) (UNII: ZYD53NBL45)
Edetate Disodium (UNII: 7FLD91C86K)
Glyceryl Monostearate (UNII: 230OU9XXE4)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Stearic Acid (UNII: 4ELV7Z65AP)
Potassium Hydroxide (UNII: WZH3C48M4T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24488-024-03	74 mL in 1 BOTTLE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/10/2010

Labeler - Fortune Hi-Tech Marketing, Inc (961956229)

Registrant - Creations Garden Natural Products, Inc. (961956229)

Establishment
Name	Address	ID/FEI	Business Operations
Creations Garden Natural Products, Inc.		961956229	manufacture