CELADRIN - menthol cream 
Natural Factors Nutritional Products Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient

Menthol 1.5%

Purpose

Pain relieving cream

Use

Temporarily relieves minor aches and pains of muscles
and joints associated with:
simple backache
arthritis
strains
bruises
sprains

Warnings

For external use only

Do not use

on wounds or damaged skin

When using this product

Stop use and ask a doctor if

Keep out of reach of children


Directions

Inactive Ingredients

aloe vera gel, celadrin® proprietary blend of esterified fatty acids (7.5%), cetyl alcohol, cinnamon oil, eucalyptus oil, glyceryl stearate, grape seed oil, hypromellose, jojoba oil, peppermint oil, potassium sorbate, purified water, squalane, stearic acid, stearyl alcohol, tea tree oil, vegetable glycerin, wintergreen oil.

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CELADRIN 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31586-2683
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CINNAMON OIL (UNII: E5GY4I6YCZ)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYPROMELLOSE (UNII: 3NXW29V3WO)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
SQUALANE (UNII: GW89575KF9)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
GLYCERIN (UNII: PDC6A3C0OX)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
JOJOBA OIL (UNII: 724GKU717M)  
TEA TREE OIL (UNII: VIF565UC2G)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:31586-2683-157 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/30/2007
Labeler - Natural Factors Nutritional Products Ltd (205628329)
Establishment
NameAddressID/FEIBusiness Operations
Natural Factors Nutritional Products Ltd 205628329manufacture

Revised: 4/2010
Document Id: 518cb3cf-987a-425f-8679-7f17b710c175
Set id: 66749e72-8a80-4330-b2d2-0b63d25344bf
Version: 4
Effective Time: 20100420
 
Natural Factors Nutritional Products Ltd