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Caring Mills Vaginal Anti-Itch Cream

Caring Mills Vaginal Anti-Itch Cream

Approved
Approval ID

cd379e74-2841-47e4-b95a-de1b341b397f

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 15, 2025

Manufacturers
FDA

Veridian Healthcare

DUNS: 830437997

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

BENZOCAINE, RESORCINOL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71101-039
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
BENZOCAINE, RESORCINOL
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 15, 2025
FDA Product Classification

INGREDIENTS (22)

PEG-100 MONOSTEARATEInactive
Code: YD01N1999R
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
CHOLECALCIFEROLInactive
Code: 1C6V77QF41
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
VITAMIN A PALMITATEInactive
Code: 1D1K0N0VVC
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
ISOPROPYL STEARATEInactive
Code: 43253ZW1MZ
Classification: IACT
TRISODIUM EDTAInactive
Code: 420IP921MB
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CARBOMER HOMOPOLYMER TYPE CInactive
Code: 4Q93RCW27E
Classification: IACT
BENZOCAINEActive
Quantity: 5.6 g in 28 g
Code: U3RSY48JW5
Classification: ACTIB
RESORCINOLActive
Quantity: 0.84 g in 28 g
Code: YUL4LO94HK
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/15/2025

Caring Mills Vaginal Anti-Itch Cream

Caring Mills Vaginal Anti-Itch Cream

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/15/2025

Use

temporarily relieves itching

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 9/15/2025

Do not apply

Do not applyover large area of the body.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 9/15/2025

Other Information

store at 20° -25° C (68° -77° F)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/15/2025

Keep out of reach of children

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/15/2025

Drug Facts Active ingredients

Benzocaine 20%

Resorcinol 3%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/15/2025

Purpose

External analgesic

WARNINGS SECTION

LOINC: 34071-1Updated: 9/15/2025

Warnings

For external use only

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 9/15/2025

When using this product

avoid contact with the eyes

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/15/2025

Stop use and ask a doctor if

condition worsens, or if symptoms persist for more than7 days or clear up and occur again within a few days

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/15/2025

Directions

adults and children 2 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 2 years

do not use; consult a doctor

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/15/2025

Inactive Ingredients

Inactive ingredients

aloe vera leaf, alpha tocopherol,butylated hydroxytoluene,carbomer, cetyl alcoholcholecalciferol, glycerylmonostearate, isopropyl myristate,

isopropyl palmitate, isopropyl stearate, mineral oil, PEG 100 stearate, PEG 400, phenoxy ethanol, propylene glycol, sodium hydroxide,
sodium lauryl sulfate, trisodium edta, vitamin a palmitate, water

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/15/2025

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1-866-326-1313

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Caring Mills Vaginal Anti-Itch Cream - FDA Drug Approval Details