MAXIMUM STRENGTH FEMININE ANTI-ITCH FAMILY WELLNESS- benzocaine 20.00% resorcinol 3.00% cream 
Family Dollar

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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Drug Facts

Active Ingredients                          Purpose
Benzocaine - 20.00%                       External analgesic
Resorcinol - 3.00%                           External analgesic

Uses Temporarily relieves itching

Warnings
For external use only

When using this product avoid contact with the eyes.

Stop use and ask a doctor if rash occurs
• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days
Do not apply over large areas of the body

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

Directions. Adults and children 6 to under 12 years and older: apply a fingertip amount (approximately 1 inch strip) to the affected area not more than 3 to 4 times daily. Children under 12 years: ask a doctor

Inactive ingredients

Water
Mineral Oil
Cetyl Alcohol
Propylene Glycol
Glyceryl Stearate
PEG-100 Stearate
Isopropyl Palmitate
Aloe Barbadensis Leaf Juice
Tocopheryl Acetate
Retinyl Palmitate
Zea Mays (Corn) Oil
Cholecalciferol
Lanolin Alcohol
Fragrance
Methylparaben
Carbomer
Isopropyl Myristate
Isopropyl Stearate
Sodium Sulfite
Triethanolamine
Trisodium HEDTA

image description

MAXIMUM STRENGTH FEMININE ANTI-ITCH  FAMILY WELLNESS
benzocaine 20.00% resorcinol 3.00% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-111
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
Water (UNII: 059QF0KO0R)  
Mineral Oil (UNII: T5L8T28FGP)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Propylene Glycol (UNII: 6DC9Q167V3)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 Stearate (UNII: YD01N1999R)  
Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
ALOE (UNII: V5VD430YW9)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
CORN OIL (UNII: 8470G57WFM)  
Cholecalciferol (UNII: 1C6V77QF41)  
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
Methylparaben (UNII: A2I8C7HI9T)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
Isopropyl Myristate (UNII: 0RE8K4LNJS)  
Isopropyl Stearate (UNII: 43253ZW1MZ)  
Sodium Sulfite (UNII: VTK01UQK3G)  
TROLAMINE (UNII: 9O3K93S3TK)  
Trisodium HEDTA (UNII: K3E0U7O8KI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-111-011 in 1 CARTON11/28/2014
128 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 finalpart34811/28/201402/21/2018
Labeler - Family Dollar (024472631)
Registrant - Product Quest mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest mfg927768135manufacture(55319-111) , label(55319-111)

Revised: 2/2018
Document Id: 78c81a94-bfd2-4b3e-8540-8467a6fda632
Set id: 4483dfba-61d6-4ce7-927d-f3543045e8a3
Version: 2
Effective Time: 20180222
 
Family Dollar