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Apeaz Ultra by Innovus Pharmaceuticals, Inc.

Medically reviewed on January 29, 2018.

Dosage form: cream
Ingredients: CAMPHOR (SYNTHETIC) 4.0mg in 1g, MENTHOL 7.5mg in 1g, METHYL SALICYLATE 10mg in 1g
Labeler: Innovus Pharmaceuticals, Inc.
NDC Code: 57483-101

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.

Apeaz Ultra

Active ingredient

Camphor 4%

Menthol 7.5%

Methyl Salicylate 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.

Do not use
  • on wounds or damaged, broken or irritated skin
  • with a heating pad

When using this product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop use and ask a doctor
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

Keep out of reach of children

If swallowed, get medical help or contact a Poison 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

Other information

store at 20° to 25°C (68° to 77°F)

Do not purchase if outer seal is broken

Inactive ingredients

carbomer, cetearyl alcohol, water, FD&C Blue no 1, FD&C Yellow no 5, glucosamine sulfate, glyceryl monostearate, methyl sulfonyl methane, methylparaben, mineral oil 90, PEG-100, propylparaben, polysorbate 60, stearyl alcohol, triethanolamine

APEAZ ULTRA 
camphor (synthetic), menthol, and methyl salicylate cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57483-101
Route of AdministrationTopicalDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)4.0 mg  in 1 g
MENTHOL (MENTHOL) MENTHOL7.5 mg  in 1 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CETOSTEARYL ALCOHOL 
STEARYL ALCOHOL 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
MINERAL OIL 
METHYLPARABEN 
PROPYLPARABEN 
POLYSORBATE 60 
DIMETHYL SULFONE 
GLUCOSAMINE SULFATE 
TROLAMINE 
CARBOMER 940 
FD&C YELLOW NO. 5 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:57483-101-011 CONTAINER in 1 CARTON
156.7 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/05/2018
Labeler - Innovus Pharmaceuticals, Inc. (962507187)
Registrant - Innovus Pharmaceuticals, Inc. (962507187)

 
Innovus Pharmaceuticals, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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