True Essentials Pain Relief Roll On (Camphor, Menthol, And Methyl Salicylate) Gel [Fortune Hi-Tech Marketing, Inc] -

TRUE ESSENTIALS PAIN RELIEF ROLL ON (CAMPHOR, MENTHOL, AND METHYL SALICYLATE) GEL [FORTUNE HI-TECH MARKETING, INC]
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NDC	24488-024-03
Set ID	38dd20d8-7a31-41c5-9288-8d42e780b80a
Category	HUMAN OTC DRUG LABEL
Packager	Fortune Hi-Tech Marketing, Inc
Generic Name
Product Class
Product Number
Application Number	PART341

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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

Placeholder Text

INGREDIENTS AND APPEARANCE

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

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

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

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

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