PAIN RELIEVING  ULTRA STRENGTH- camphor menthol methyl salicylate cream 
Creation's Garden Natural Products, Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

Drug Facts

Camphor 4% .……..…….............….. Topical Analgesic
Menthol 10% ...……......……….....… Topical Analgesic
Methyl Salicylate 30% .......….......… 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

Directions

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 ingredients

Inactive ingredients
water, carbomer, disodium edta, glyceryl stearate se,
lanolin, polysorbate 80, stearic acid, triethanolamine,
potassium hydroxide

Questions?

Questions? Call 1-866-923-4914

image of tube label

image of carton label

PAIN RELIEVING   ULTRA STRENGTH
camphor menthol methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24488-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)2.28 g  in 57 g
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol5.7 g  in 57 g
Methyl Salicylate (UNII: LAV5U5022Y) (Methyl Salicylate - UNII:LAV5U5022Y) Methyl Salicylate9 g  in 57 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Carbomer Homopolymer Type C (UNII: 4Q93RCW27E)  
Edetate Disodium (UNII: 7FLD91C86K)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Lanolin (UNII: 7EV65EAW6H)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Trolamine (UNII: 9O3K93S3TK)  
Potassium Hydroxide (UNII: WZH3C48M4T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24488-001-111 in 1 CARTON
157 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/31/2010
Labeler - Creation's Garden Natural Products, Inc (839471216)
Registrant - Creation's Garden Natural Products, Inc (839471216)
Establishment
NameAddressID/FEIBusiness Operations
Creation's Garden Natural Products, Inc839471216manufacture

Revised: 3/2010
Document Id: 198d5e56-8559-42c1-a5be-35094578ae7d
Set id: 69f852e3-654c-42db-87c6-0d3b1b48bf05
Version: 1
Effective Time: 20100331
 
Creation's Garden Natural Products, Inc