FDA.reportPublic FDA data

GeriGard

Manufacturer
Geri-Gentle Corporation
Effective date
2025-10-27
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 01:40:55

Label at a glance#

ProductGeriGard
Active ingredientZINC OXIDE
Label structure7 sections

Indications and uses

Helps treat and prevent diaper rash. Helps seal out wetness. Dries the oozing and weeping of: poison ivy  poison oak  poison sumac

Dosage and administration

Apply liberally as needed For diaper rash:  change wet and soiled diapers promptly  allow to dry Apply ointment liberally with each diaper change

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (1.8% w/w)

Purpose

OTC - PURPOSE SECTION

Skin Prorectant

Uses:

INDICATIONS & USAGE SECTION

  • Helps treat and prevent diaper rash.
  • Helps seal out wetness.
  • Dries the oozing and weeping of:
  • poison ivy 
  • poison oak 
  • poison sumac

Warnings:

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • Do not get into eyes

Stop use nd ask a doctor if:

OTC - STOP USE SECTION

  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again in a few days, consult a physician

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally as needed
  • For diaper rash: 
  • change wet and soiled diapers promptly 
  • allow to dry
  • Apply ointment liberally with each diaper change

Other information:

SPL UNCLASSIFIED SECTION

  • Store at room temperature 15º - 30ºC (59º - 86ºF)
  • Avoid excessive heat
  • Contains color additives including FD&C Yellow No. 5 (Tartrazine).

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Aloe Vera Leaf, Alpha-Tocopherol, Ceteth-10, Cetostearyl Alcohol, Cetyl Alcohol, Cholecalciferol, Glycerin, Lanolin, Lavender, Methylparaben, Mineral Oil, Paraffin, Petrolatum, Phenoxyethanol, Polyethylene Glycol 6000, Polysorbate 60, Propylparaben Sodium, Steareth-20, Trolamine, Vitamin A, Water.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

gerigeri

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1044412zinc oxide 1.8 % Topical OintmentPSN12
1044412zinc oxide 0.018 MG/MG Topical OintmentSCD12
1044412zinc oxide 1.8 % Topical OintmentSY12
1044412ZNO 0.018 MG/MG Topical OintmentSY12

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69771-050-042024-01-30C16284748780-10191ceaa-7032-198a-e063-dbdaa90aec3eGeriGard
69771-050-042024-01-30C16284748780-10191ceaa-7032-198a-e063-dbdaa90aec3eGeriGard
69771-050-042023-11-10C16284748780-10191ceaa-7032-198a-e063-dbdaa90aec3eGeriGard
69771-050-042023-11-10C16284748780-10191ceaa-7032-198a-e063-dbdaa90aec3eGeriGard
69771-050-042023-07-28C16284748780-10191ceaa-7032-198a-e063-dbdaa90aec3eGeriGard
69771-050-042023-07-28C16284748780-10191ceaa-7032-198a-e063-dbdaa90aec3eGeriGard

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69771-050-04GeriGard24 in 1 CASEOINTMENT2412
69771-050-04GeriGard113 g in 1 TUBEOINTMENT11312

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69771-05069771-050-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ALPHA-TOCOPHEROLH4N855PNZ1IACT
CETETH-10LF9X1PN3XJIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ALCOHOL936JST6JCNIACT
CHOLECALCIFEROL1C6V77QF41IACT
GLYCERINPDC6A3C0OXIACT
LANOLIN7EV65EAW6HIACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
PARAFFINI9O0E3H2ZEIACT
PETROLATUM4T6H12BN9UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYETHYLENE GLYCOL 600030IQX730WEIACT
POLYSORBATE 60CAL22UVI4MIACT
PROPYLPARABEN SODIUM625NNB0G9NIACT
STEARETH-20L0Q8IK9E08IACT
TROLAMINE9O3K93S3TKIACT
VITAMIN A81G40H8B0TIACT
WATER059QF0KO0RIACT
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
102024-07-16full-release2026-06-01 00:15:23

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
GeriGardZINC OXIDEGeri-Gentle Corporation05b67830-adc8-46b1-b0a0-a6cd2875e80c2025-10-27WarningsExact identifier
ndc (package): 69771-050-04
ndc (product): 69771-050
ndc11 (package): 69771005004
spl id: 42297230-d3d0-3f77-e063-6294a90ab140
spl set id: 05b67830-adc8-46b1-b0a0-a6cd2875e80c

Reported adverse events (FAERS/openFDA)#

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