APEAZ ULTRA- camphor (synthetic), menthol and methyl salicylate 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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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

image description

APEAZ ULTRA
camphor, menthol, methyl salicylate cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57483-001
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC))	CAMPHOR (SYNTHETIC)	40 mg in 1 g
MENTHOL (MENTHOL)	MENTHOL	100 mg in 1 g
METHYL SALICYLATE (SALICYLIC ACID)	METHYL SALICYLATE	300 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN
PROPYLPARABEN
POLYSORBATE 80
PEG-100 STEARATE
PETROLATUM
WATER
CARBOMER HOMOPOLYMER TYPE C
DMDM HYDANTOIN
EDETIC ACID
GLYCOL STEARATE
STEARIC ACID

Packaging
#	Item Code	Package Description
1	NDC:57483-001-04	56.7 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/06/2013

Labeler - Innovus Pharmaceuticals, Inc. (962507187)

Establishment
Name	Address	ID/FEI	Business Operations
Topical Pharmaceuticals, Inc.		831530683	manufacture(57483-001)

Revised: 08/2013

Document Id: 7e7bb8ca-be0a-46b1-b359-947e1588321e

Set id: 9f36e226-9e8b-4282-9699-84fc7ac499c4

Version: 1

Effective Time: 20130806

Innovus Pharmaceuticals, Inc.