SELECT BRAND ANTI-ITCH- menthol and pramoxine hydrochloride cream 
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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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Select Brand Anti-Itch

Drug Facts

Active ingredients

Menthol 1%

Pramoxine hydrochloride 1%

Purpose

Topical analgesic

Uses

for temporary relief of pain and itching due to:

Warnings

For external use only

When using this product

do not get into eyes

Stop use and ask a doctor if

  • condition gets worse
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 2 years and older: apply to affected area not more than 3 or 4 times daily

children under 2 years: consult a doctor

Other Information

Inactive ingredients

aloe barbadensis (aloe vera) leaf juice, diazolidinyl urea, edetate disodium, eucalyptus oil, methylparaben, methyl salicylate, mineral oil, PPG-1 trideceth-6, propylene glycol, propylparaben, purified water, sodium acrylates copolymer, steareth-21, stearyl alcohol, tocopheryl acetate, trolamine, white petrolatum

PRINCIPAL DISPLAY PANEL

Select Brand Medicated Anti-Itch Cream

Maximum Relief

Topical Analgesic

Net wt 1 oz (28.3 g)

PDP

rear

SELECT BRAND ANTI-ITCH 
menthol and pramoxine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-721
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE.1 g  in 10 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM.1 g  in 10 g
Inactive Ingredients
Ingredient NameStrength
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
SODIUM ACRYLATE (UNII: 7C98FKB43H)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MINERAL OIL (UNII: T5L8T28FGP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
TROLAMINE (UNII: 9O3K93S3TK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15127-721-011 in 1 CARTON01/03/2014
128.3 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/03/2012
Labeler - Select Brand (043562370)
Registrant - Weeks & Leo Co., Inc. (005290028)
Establishment
NameAddressID/FEIBusiness Operations
Weeks & Leo Co., Inc.005290028label(15127-721) , manufacture(15127-721) , pack(15127-721)

Revised: 1/2015
Document Id: 0bacd190-b119-0df3-e054-00144ff8d46c
Set id: 0bacd190-b118-0df3-e054-00144ff8d46c
Version: 9
Effective Time: 20150112
 
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