CETILAR- menthol 1.4% cream 
PharmaNutra Usa Corp.

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Cetilar

Active Ingredient

Menthol 1.4%

Purpose

Topical Analgesic

Use

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Warnings

For external use only. Avoid contact with eyes

When using this product

  • Do not bandage tightly
  • do not apply to wounds or damage skin

Stop use and ask a doctor

  • if condition worsens
  • if symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding

ask a health professional before use

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Adults and children over 12 years:

Children 12 years or younger, consult a doctor

Other Information

The product must be stored at temperature between 50-86 °F (10-30ºC), in a dry place away from light localized heat sources.

Inactive ingredients

water, cetyl myristate, Glycerin, Cetyl alcohol, Glyceryl stearate, olea europea (olive ) oil unsaponifiables, cetyloleate, Butylene glycol, Caprylic capric triglyceride, prunus armeniaca (apricot) kenel oil, Beeswax, Phenoxyethanol, Triethanolamine, carbomer, fragrance, isopropyl myristate, ethylhexylglycerin, triticum vulgare (wheat) germ oil, BHT, tocopheryl acetate.

box

CETILAR 
menthol 1.4% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84797-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
APRICOT SEED OIL (UNII: 54JB35T06A)  
WATER (UNII: 059QF0KO0R)  
GLYCERYL STEARATE (UNII: 230OU9XXE4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)  
TRIETHANOLAMINE (UNII: 9O3K93S3TK)  
WHEAT GERM OIL UNSAPONIFIABLES (UNII: 6AXM7XCV3D)  
BEESWAX (UNII: 2ZA36H0S2V)  
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CETYL MYRISTATE (UNII: 7OPL833Q4D)  
PERFLUOROPOLYMETHYLISOPROPYL ETHER (UNII: X6324K3MBW)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84797-000-491 in 1 CARTON02/01/2025
149 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01702/01/2025
Labeler - PharmaNutra Usa Corp. (119066016)
Establishment
NameAddressID/FEIBusiness Operations
Biofarma SRL507836496manufacture(84797-000)

Revised: 2/2025
Document Id: 2dd14e68-9b33-bad8-e063-6394a90a9fc1
Set id: 2dd14bd4-b4e1-bc7d-e063-6394a90a1e59
Version: 1
Effective Time: 20250204
 
PharmaNutra Usa Corp.