FDA.reportPublic FDA data

glo SKIN BEAUTY Remedy Gel

Manufacturer
Hayden Caleel LLC | Island Kinetics, Inc. d.b.a. CoValence Laboratories
Effective date
2025-01-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:50:50

Label at a glance#

Productglo SKIN BEAUTY Remedy Gel
Active ingredientHYDROCORTISONE
Label structure8 sections

Indications and uses

temporarily relieves itching associate with minor skin irritations, inflammation an rashes due to: dermatitis, exzema, insect bites other uses of this prouct should be only under the advice and supervision of a doctor

Dosage and administration

for itching of skin irritation, inflamation and rashes adults an chilren 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: do not use, ask a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Anti-itch

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves itching associate with minor skin irritations, inflammation an rashes due to:
  • dermatitis, exzema, insect bites
  • other uses of this prouct should be only under the advice and supervision of a doctor

Warnings

WARNINGS SECTION

For external use only

Do not use

  • for the treatment of iaper rash. Ask a doctor

When using this product
• avoid contact with the eyes
• do not use more than directed unless told to do so by a doctor

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, and do not begin use of any other hyrdrocortisone product unless you have asked a doctor

Keep out of reach of children

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

  • for itching of skin irritation, inflamation and rashes
  • adults an chilren 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: do not use, ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water), Glycerin, Caprylic/Capric Triglyceride, Cetearyl Olivate, Rosa Canina (Rose Hip) Fruit Oil, Squalane, Sorbitan Olivate, Bisabolol, Carbomer, Gluconolactone, Lonicera Caprifolium (Honeysuckle) Flower Extract, Hedychium Coronarium (White Ginger) Root Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Sodium Benzoate, Phenethyl Alcohol, Potassium Sorbate, Caprylyl Glycol, Tocopherol, Glycine Soja (Soybean) Oil, Aloe Barbadensis Leaf Juice Powder, Phytic Acid, Sodium Hydroxide, Xanthan Gum, Trisodium Ethylenediamine Disuccinate

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

541-1900-3541-1900-3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198706hydrocortisone 1 % Topical GelPSN3
198706hydrocortisone 0.01 MG/MG Topical GelSCD3
198706hydrocortisone 1 % Topical GelSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROCORTISONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60541-1900-32020-01-31C16284748780-19d75b9d0-43cc-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60541-1900-3glo SKIN BEAUTY Remedy Gel1 in 1 CARTONGEL13
60541-1900-3glo SKIN BEAUTY Remedy Gel30 g in 1 BOTTLEGEL303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60541-1900GLO SKIN BEAUTY REMEDY GEL GEL [HAYDEN CALEEL LLC]3Current NDC, Legacy NDC, 2 package rows20250107_aa47ff08-07b3-4fd1-bae5-420e4b928f06.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
60541-190060541-1900-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
CAPRYLIC/CAPRIC ACIDDI775RT244IACT
ROSA CANINA FRUIT OILCR7307M3QZIACT
SQUALANEGW89575KF9IACT
SORBITAN OLIVATEMDL271E3GRIACT
.ALPHA.-BISABOLOL, (+)-105S6I733ZIACT
CARBOMER 9404Q93RCW27EIACT
GLUCONOLACTONEWQ29KQ9POTIACT
LONICERA CAPRIFOLIUM FLOWER5N1WD9784UIACT
HEDYCHIUM CORONARIUM ROOT92A6N0IQN9IACT
LONICERA JAPONICA FLOWER4465L2WS4YIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CAPRYLYL GLYCOL00YIU5438UIACT
TOCOPHEROLR0ZB2556P8IACT
SOYBEAN OIL241ATL177AIACT
ALOE VERA WHOLEKIZ4X2EHYXIACT
SODIUM HYDRIDE23J3BHR95OIACT
XANTHAN GUMTTV12P4NEEIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
HYDROCORTISONEWI4X0X7BPJACTIB

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
glo SKIN BEAUTY Remedy GelGLO SKIN BEAUTY REMEDY GELHayden Caleel LLCaa47ff08-07b3-4fd1-bae5-420e4b928f062025-01-05WarningsExact identifier
ndc (package): 60541-1900-3
ndc (product): 60541-1900
ndc11 (package): 60541190003
spl id: 2af7cc72-4838-9f49-e063-6294a90a7adc
spl set id: aa47ff08-07b3-4fd1-bae5-420e4b928f06

Reported adverse events (FAERS/openFDA)#

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