CREATIONS GARDEN PAIN RELIEF ROLL ON- camphor, menthol, and methyl salicylate gel

Creations Garden by

Drug Labeling and Warnings

Creations Garden by is a Otc medication manufactured, distributed, or labeled by 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

Placeholder Text

INGREDIENTS AND APPEARANCE

CREATIONS GARDEN  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: 24488-024-26	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 - Creations Garden Natural Products, Inc. (961956229)

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

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