VALTRUM ANALGESIC- camphor (synthetic), menthol, menthyl salicylate gel 
Laboratorios Quantium LLC

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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Valtrum Topical Analgesic Gel

Drug Facts

Active Ingredients

Camphor 3%
Menthol 3%
Menthyl salicilate 10%

Purpose

Topical analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with

• Simple Backache • Arthritis • Strains • Bruises • Sprains

Warnings

For external use only

Caution: Discontinue use if excessive irritation of the skin develops.

When using this product:

  • Do not bandage tightly
  • Do not apply to wounds or damaged skin.

Stop use and ask a doctor if:

  • Conditions worsens
  • 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 18 years of age and older: Apply to affected area not more than 3 to 4 times daily.  Children under 18 years of age: Consult a doctor.

Other information

Inactive Ingredients:

Arnica Montana Extract, Carbopol 940, Cat's Claw Extract, Chuchuhuasi Extract, Devil's Claw Extract, Glucosamine Sulfate, Isopropil Alcohol, Peg 40 Castor Oil, Purified Water, Triethanolamine.

Package Labeling:

Label

VALTRUM ANALGESIC 
camphor (synthetic), menthol, menthyl salicylate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75849-312
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)30 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL30 mg  in 1 g
MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD) (SALICYLIC ACID - UNII:O414PZ4LPZ) MENTHYL SALICYLATE, (+/-)-100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CAT'S CLAW (UNII: 9060PRM18Q)  
MAYTENUS KRUKOVII BARK (UNII: K50SD0PDVR)  
ARNICA MONTANA WHOLE (UNII: O80TY208ZW)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75849-312-0390 g in 1 TUBE; Type 0: Not a Combination Product07/15/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/15/2021
Labeler - Laboratorios Quantium LLC (027101451)
Establishment
NameAddressID/FEIBusiness Operations
GADAL Laboratories, Inc841305639manufacture(75849-312) , label(75849-312) , pack(75849-312)

Revised: 8/2021
Document Id: c9ed6773-b657-720c-e053-2a95a90ae2b1
Set id: c72e768c-d1ee-ba0b-e053-2a95a90a5f99
Version: 3
Effective Time: 20210819
 
Laboratorios Quantium LLC