APEAZ ULTRA- camphor (synthetic), menthol, and methyl salicylate cream cream 
Innovus Pharmaceuticals, Inc.

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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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:

Warnings​

For external use only.

Do not use

When using this product

Stop use and ask a doctor

Keep out of reach of children

If swallowed, get medical help or contact a Poison Center immediately

Directions

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

image description

APEAZ ULTRA 
camphor (synthetic), menthol, and methyl salicylate cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57483-101
Route of AdministrationTopical
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4.0 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.5 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
MINERAL OIL (UNII: T5L8T28FGP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57483-101-011 in 1 CARTON02/05/2018
156.7 g in 1 CONTAINER; Type 0: Not a Combination Product
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)

Revised: 1/2023
Document Id: decac180-c70c-437b-8f6f-1fd59a4176bc
Set id: ec93ca9d-ef59-456f-ac08-d50936f70424
Version: 3
Effective Time: 20230127
 
Innovus Pharmaceuticals, Inc.