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Diaper Rash

HEB Hill Country 020.002/020AC-AD Diaper Rash Ointment 40% Zinc Oxide

Approved
Approval ID

f0b31d52-2903-487a-aa70-0dbdf4c4d7e7

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 3, 2025

Manufacturers
FDA

H E B

DUNS: 007924756

Products 1

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

Zinc oxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code37808-020
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
Zinc oxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 3, 2025
FDA Product Classification

INGREDIENTS (9)

GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SORBITAN SESQUIOLEATEInactive
Code: 0W8RRI5W5A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
COD LIVER OILInactive
Code: BBL281NWFG
Classification: IACT
LANOLINInactive
Code: 7EV65EAW6H
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
ZINC OXIDEActive
Quantity: 400 mg in 1 g
Code: SOI2LOH54Z
Classification: ACTIB
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/3/2025

Principal display panel

HILL COUNTRY FARE ®

Diaper Rash Paste

SKIN PROTECTANT

40% ZINC OXIDE

Helps Soothe & Prevent Diaper Rash

FREE FROM

  • parabens
  • phthalates
  • dyes

NET WT. 4 OZ

CONT. NET. 113 g

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/3/2025

Uses

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 9/3/2025

Adverse Reactions

KEEP THIS CARTON FOR FULL PRODUCT INFORMATION

DISTRIBUTED BY: H-E-B ®, SAN ANTONIO, TN 78204

LOT NUMBER: ON PACKAGE

QUESTIONS OR COMMENTS? CALL TOLL FREE 1-888-593-0593

WE HOPE YOU ARE SATISFIED WITH THIS PRODUCT. IF NOT, WE WILL CHEERFULLY REFUND YOUR MONEY.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/3/2025

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/3/2025

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/3/2025

Directions

  • change wet and soilded diapers promptly
  • cleanse the diaper area
  • allow to dry
  • apply paste liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/3/2025

Active ingredient

Zinc oxide 40%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/3/2025

Purpose

Skin protectant

WARNINGS SECTION

LOINC: 34071-1Updated: 9/3/2025

Warnings

For external use only

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 9/3/2025

When using this product

  • do not get into eyes

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/3/2025

Other information

store between 20⁰ and 25⁰C (68⁰ and 77⁰F)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/3/2025

Inactive ingredients

petrolatum, cod liver oil, lanolin, Zea mays (corn) starch, glycerin, sorbitan sesquioleate, beeswax, tocopheryl acetate, fragrance

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