ANTI ITCH  MAXIMUM RELIEF- pramoxine hydrochloride and menthol cream 
Natureplex LLC

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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Anti-Itch Cream
Maximum Relief

Drug Facts

Active ingredientsPurpose
Menthol 1%Topical Analgesic
Pramoxine hydrochloride 1%Topical Analgesic

Use

For temporary relief of pain and itching associated with minor skin irritations, minor burns, minor cuts, sunburns, scrapes, insect bites, and rashes due to poison ivy, poison oak, or poison sumac

Warnings

For external use only.

Avoid contact with eyes and nose.

Not for prolonged use.

Do not use

  • on large areas of the body

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness, irritation, swelling, or pain develops, persists, or increases

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

Other information

Inactive ingredients

aloe barbadensis leaf juice, carbomer, cetearyl alcohol, DMDM hydantoin, glycerin, polysorbate 60, propylene glycol, purified water, triethanolamine

Questions or comments?

866-323-0107 or www.natureplex.com

PRINCIPAL DISPLAY PANEL - 42.5 g Tube Box

Natureplex

MAXIMUM RELIEF

Medicated
Anti-Itch Cream

NET WT. 1.5 Oz. (42.5g)

Principal Display Panel - 42.5 g Tube Box
ANTI ITCH   MAXIMUM RELIEF
pramoxine hydrochloride and menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine Hydrochloride10 mg  in 1 g
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67234-008-011 in 1 BOX01/02/2008
142 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34701/02/2008
Labeler - Natureplex LLC (062808196)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex LLC062808196MANUFACTURE(67234-008)

Revised: 11/2017
Document Id: 23ac82ee-44e5-452d-aef5-e50e07febcd6
Set id: 75de3d5e-ecbe-4d04-a39d-792200e6ee32
Version: 2
Effective Time: 20171128
 
Natureplex LLC