REXALL FEMININE MAXIMUM STRENGTH ANTI-ITCH- benzocaine and resorcinol 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.

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REXALL FEMININE MAXIMUM STRENGTH ANTI-ITCH CREAM

Active ingredients

Benzocaine 20%

Resorcinol 3%

Purpose

External Analgesic

External Analgesic

Use

Warnings

For external use only

When using this product avoid contact with eyes

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Also, do not use if you have an unusual or abnormal vaginal discharge except under the supervision of a physician.

Do not apply over large areas of the body.

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

Directions

adults and children 12 years and older

apply a fingertip amount (approximately 1-inch strip) to Tthe affected area not more than 3 to 4 times daily

children under 12 years

consult a doctor

Other information

store at 20°-25°C (68°-77°F)

Inactive ingredients

aloe vera gel, carbomer, cetyl alcohol, corn oil, disodium EDTA, fragrance, glyceryl stearate, isopropyl myristate, isopropyl palmitate, lanolin, methyl-4 hydroxybenzoate, mineral oil, PEG-100 stearate, propylene glycol, purified water, stearic acid, stearyl alcohol, triethanolamine, vitamin A, E & D

Principal display panel - 28 g Carton Label

REXALL FEMININE MAXIMUM STRENGTH ANTI-ITCH CREAM

NET WT 1 OZ (28 g)

label of anti-itch

REXALL FEMININE MAXIMUM STRENGTH ANTI-ITCH 
benzocaine and resorcinol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-415
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CORN OIL (UNII: 8470G57WFM)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
LANOLIN (UNII: 7EV65EAW6H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
TROLAMINE (UNII: 9O3K93S3TK)  
VITAMIN A (UNII: 81G40H8B0T)  
VITAMIN D (UNII: 9VU1KI44GP)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-415-0328 g in 1 TUBE; Type 0: Not a Combination Product09/27/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34609/27/2016
Labeler - Dolgencorp, Inc. (068331990)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(55910-415)

Revised: 9/2016
Document Id: 3d941002-457d-304e-e054-00144ff8d46c
Set id: 6f0adbd8-997d-4c56-845e-82f721b19463
Version: 1
Effective Time: 20160928
 
Dolgencorp, Inc.