Apeaz Ultra by Topical Pharmaceuticals Inc. Apeaz Ultra

Apeaz Ultra by

Drug Labeling and Warnings

Apeaz Ultra by is a Otc medication manufactured, distributed, or labeled by Topical Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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

Packaging

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15478-111
Route of Administration	Topical

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	40 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	75 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PEG-100 STEARATE (UNII: YD01N1999R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POLYSORBATE 60 (UNII: CAL22UVI4M)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15478-111-04	1 in 1 CARTON	02/05/2018
1		56.7 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/05/2018

Labeler - Topical Pharmaceuticals Inc. (831530683)

Establishment
Name	Address	ID/FEI	Business Operations
Topical Pharmaceuticals Inc.		831530683	manufacture(15478-111)

Revised: 1/2021

Document Id: 3560957d-2a24-4eec-9e19-a572d501d5ed

34390-5

Set id: 66ed976f-b45c-4e1c-aa69-9e53615f2d45

Version: 1

Effective Time: 20210114