FDA.reportPublic FDA data

Family Care Anti-Itch + Pain Relief Cream 0.5oz (10497)

Manufacturer
United Exchange Corp.
Effective date
2025-10-21
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
full-release
Hydrated at
2026-06-01 01:40:07

Label at a glance#

ProductFamily Care Maximum Strength Medicated Anti Itch
Active ingredientMENTHOL, PRAMOXINE HYDROCHLORIDE
Label structure14 sections

Storage and handling

Other information store at room temperature 20-25°C (68-77°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

Menthol 1%.........................................................................Anti-itch/Topical analgesic

Pramoxine HCl 1%..............................................................Anti-itch/Topical analgesic

OTC - PURPOSE SECTION

Uses

  • for temporary relief of pain and itching associated with:
  • minor skin irritations
  • minor cuts
  • minor burns
  • minor sunburns
  • scrapes
  • insect bites
  • rashes due to poison ivy, oak, or sumac

WARNINGS SECTION

Warnings For external use only.

OTC - DO NOT USE SECTION

Do not use

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

OTC - WHEN USING SECTION

When using this product, avoid contact with eyes or nose.

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison control Center (1-800-222-1222) right away.

INDICATIONS & USAGE SECTION

Directions

  • not for prolonged use
  • adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor.

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients aloe vera leaf, carbomer 940, glycerin, glyceryl monostearate, isopropyl myristate, methyl salicylate, methylparaben, mineral oil, polysorbate 60, propylparaben, purified water, sodium hydroxide, stearyl alcohol, tocopheryl acetate

OTC - QUESTIONS SECTION

Questions or comments?

Call 1-888-645-8204 Monday-Friday 9AM-5PM (PST)

DOSAGE & ADMINISTRATION SECTION

Distributed By: UNITED EXCHANGE CORPORATION

Cypress, CA 90630 USA | 1-888-645-8204

Made in China

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10497.110497.1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1116155menthol 1 % / pramoxine HCl 1 % Topical CreamPSN16
1116155menthol 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD16
1116155menthol 1 % / pramoxine hydrochloride 1 % Topical CreamSY16

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130780707104972GTIN-13: 0780707104972
EAN-13: 0780707104972
GTIN-12: 780707104972
UPC-A: 780707104972
GTIN storage (14 digits): 00780707104972		10497.1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65923-104-14Family Care Maximum Strength Medicated Anti Itch1 in 1 CARTONCREAM116
65923-104-14Family Care Maximum Strength Medicated Anti Itch14 g in 1 TUBECREAM1416

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A6
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L56
MENTHOLACTIVE MOIETYL7T10EIP3A6
PRAMOXINEACTIVE MOIETY068X84E0566
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X6
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27E6
GLYCERININACTIVE INGREDIENTPDC6A3C0OX6
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE46
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJS6
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022Y6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T6
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP6
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4M6
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH6
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1Y6
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK6
WATERINACTIVE INGREDIENT059QF0KO0R6

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65923-10465923-104-14

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER 9404Q93RCW27EIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
METHYLPARABENA2I8C7HI9TIACT
METHYL SALICYLATELAV5U5022YIACT
MINERAL OILT5L8T28FGPIACT
POLYSORBATE 60CAL22UVI4MIACT
PROPYLPARABENZ8IX2SC1OHIACT
STEARYL ALCOHOL2KR89I4H1YIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
SODIUM HYDROXIDE55X04QC32IIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
142025-03-03full-release2026-06-01 00:56:34

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 24 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPOWDER / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPOWDER / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ECREAM / TOPICAL103 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSCREAM / TOPICAL65000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YCREAM / TOPICAL162000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSCREAM / TOPICAL65000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YGEL / TOPICAL0.05 %w/wExact identifier — unii+route
4 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MCREAM / TOPICAL225 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YGEL / TOPICAL0.05 %w/wExact identifier — unii+route
4 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YCREAM / TOPICAL162000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MCREAM / TOPICAL225 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ECREAM / TOPICAL103 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Care Maximum Strength Medicated Anti ItchMENTHOLUnited Exchange Corp.430b5753-3087-4cb1-bf54-0eedc3f4b1d52025-10-21WarningsExact identifier
ndc (package): 65923-104-14
ndc (product): 65923-104
ndc11 (package): 65923010414
spl id: 41b455e2-0768-80cb-e063-6394a90a5698
spl set id: 430b5753-3087-4cb1-bf54-0eedc3f4b1d5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.