FDA.reportPublic FDA data

Gerigard-Skin Protectant

Manufacturer
Geri-Gentle Corporation | SKYLARK CMC PVT. LTD.
Effective date
2018-01-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:12

Label at a glance#

ProductGerigard-Skin Protectant
Active ingredientZinc Oxide
Label structure9 sections

Indications and uses

Helps treat and prevent diaper rash. Temporarily protects: minor cuts scrapes burns 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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (1.8% w/w)

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps treat and prevent diaper rash.
  • Temporarily protects:
    • minor cuts
    • scrapes
    • burns
  • 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 and 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

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 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PRINCIPAL DISPLAY PANEL - 113 gm Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

gerigentle™

VITAMIN ENRICHED
geri
gard™
SKIN PROTECTANT

SPECIALLY FORMULATED
FOR GENTLE SKIN

AloeSoft

VITAMIN A • VITAMIN D • VITAMIN E
ZINC OXIDE • ALOE VERA

4 FL OZ (113 gm)

Principal Display Panel - 113 gm Tube Label
Principal Display Panel - 113 gm Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1044412zinc oxide 1.8 % Topical OintmentPSN1
1044412zinc oxide 0.018 MG/MG Topical OintmentSCD1
1044412zinc oxide 1.8 % Topical OintmentSY1
1044412ZNO 0.018 MG/MG Topical OintmentSY1

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
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69771-108-372020-01-31C16284748780-19d75b9d0-3c67-f424-e053-dadaa90a57ceGerigard™-Skin Protectant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69771-108-37Gerigard-Skin Protectant113 g in 1 TUBEOINTMENT1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69771-108GERIGARD-SKIN PROTECTANT (ZINC OXIDE) OINTMENT [GERI-GENTLE CORPORATION]1Legacy NDC, 1 package rows20180120_a72e484d-a911-4870-b923-6650933ea902.zip

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
69771-10869771-108-37

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
Zinc OxideSOI2LOH54ZACTIM
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

Source Document#

Source XML

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
e78720ac-90b4-4ff0-aba4-8c4e8d0cc88aa72e484d-a911-4870-b923-6650933ea9022018-01-18WarningsExact identifier
spl id: e78720ac-90b4-4ff0-aba4-8c4e8d0cc88a
spl set id: a72e484d-a911-4870-b923-6650933ea902

Reported adverse events (FAERS/openFDA)#

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