ANTI-ITCH- menthol and pramoxine hydrochloride cream 
Dolgencorp, 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.

----------

Anti-Itch

Active ingredients

Menthol 1%

Pramoxine hydrochloride 1%

Purpose

Anti-itch, Pain relief

Uses

for temporary relief of pain and itching associated with:

Warnings

For external use only

Do not use on

  • deep or puncture wounds
  • animals bites
  • serious burns
  • large areas of the body

When using this product

  • do not get into eyes or nose
  • not for prolonged use

Stop use and ask a doctor if

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

Keep out of reach of children.

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

Directions

adults and children 2 years and older: apply to affected area up to 3 or 4 times daily

children under 2 years: consult a doctor

Inactive ingredients

aloe vera (aloe barbadensis) leaf juice, diazolidinyl urea, disodium EDTA, eucalyptol, iodopropynyl butylcarbamate, methyl salicylate, mineral oil (parraffinum liquidum), petrolatum, PPG-1 trideceth-6, propylene glycol, sodium acrylates copolymer, steareth-21, stearyl alcohol, thymol,   tocopheryl acetate (vitamin E), triethanolamine, water

Other information

PRINCIPAL DISPLAY PANEL

ANTI-ITCH CREAM

NET WT 1 OZ (28 g)

label of anti-itch

ANTI-ITCH 
menthol and pramoxine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-407
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
EUCALYPTOL (UNII: RV6J6604TK)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARETH-21 (UNII: 53J3F32P58)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
THYMOL (UNII: 3J50XA376E)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-407-0328 g in 1 TUBE; Type 0: Not a Combination Product06/30/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/30/2016
Labeler - Dolgencorp, Inc. (068331990)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(55910-407)

Revised: 7/2016
Document Id: 36a97165-e026-65cf-e054-00144ff88e88
Set id: a26f4840-9a05-45e4-a58d-0aa63729e59c
Version: 1
Effective Time: 20160701
 
Dolgencorp, Inc.