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Apeaz Ultra by Innovus Pharmaceuticals, Inc.

Medically reviewed on September 12, 2017

Dosage form: cream
Ingredients: CAMPHOR (SYNTHETIC) 40mg in 1g, MENTHOL 100mg in 1g, METHYL SALICYLATE 300mg in 1g
Labeler: Innovus Pharmaceuticals, Inc.
NDC Code: 57483-001

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.

Active Ingredients

Camphor 4%

Menthol 10%

Methyl Salicylate 30%

Purpose

topical analgesic

Uses

Temporarily relieves the 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
  • with a heating pad
  • on a child under 12 years of age
  • with arthritis like conditions

Ask a doctor before use

If you have redness over the affected area

When using this product

Avoid contact with eyes or mucus membranes
Do not bandage tightly

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

Keep out of the reach of children to acoid accidental ingestion

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

Inactive Ingredients

Lanolin USP, Ethyl & propylparabens, Polysorbate 80, PEG-100 Stearate, Petrolatum, Deionized Water, Carbopol 940, DMDM hydantion, EDTA glycol mono stearate, Stearic acid FLK triple press

Other information

Store at 20-25 (68-77F)

Questions

858-964-5123

APEAZ ULTRA 
camphor, menthol, methyl salicylate cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57483-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)40 mg  in 1 g
MENTHOL (MENTHOL) MENTHOL100 mg  in 1 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE300 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN 
PROPYLPARABEN 
POLYSORBATE 80 
PEG-100 STEARATE 
PETROLATUM 
WATER 
CARBOMER HOMOPOLYMER TYPE C 
DMDM HYDANTOIN 
EDETIC ACID 
GLYCOL STEARATE 
STEARIC ACID 
Packaging
#Item CodePackage Description
1NDC:57483-001-0456.7 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/06/2013
Labeler - Innovus Pharmaceuticals, Inc. (962507187)
Establishment
NameAddressID/FEIOperations
Geritrex Corp.112796248manufacture(57483-001)

 
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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