FDA.reportPublic FDA data

Champ

Manufacturer
Champ Products, Ltd | Aegle Nutrition LLC
Effective date
2020-05-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:16:00

Label at a glance#

ProductChamp
Active ingredientALCOHOL
Label structure7 sections

Indications and uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

Dosage and administration

Apply liberally to front and back of hands. Allow to dry. Recommended for repeated use.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally to front and back of hands. Allow to dry. Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only: hands.

Flammable, keep away from fire or flame.

When using this product avoid contact with the eyes. In case of contact, Rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or redness appears and lasts.

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

Do not use: in children less than 2 months of age and on open wounds. Do not inhale or ingest.

Supervise children under 6 years of age when using the product to avoid swallowing.

Other information

Store between 00C (320F) – 410C (1050F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Hydrogen Peroxide, Distilled Water, Polymer, Fragrance.

Customer service

1-833-SANITIZE

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78658-001-012022-01-28C16284748780-1d6a99b39-c1dd-a426-e053-dadaa90af4c2f7d9d723-e821-4d1b-a22a-9d7023029f0f
78658-001-022022-01-28C16284748780-1d6a99b39-c1dd-a426-e053-dadaa90af4c2f7d9d723-e821-4d1b-a22a-9d7023029f0f
78658-001-032022-01-28C16284748780-1d6a99b39-c1dd-a426-e053-dadaa90af4c2f7d9d723-e821-4d1b-a22a-9d7023029f0f
78658-001-042022-01-28C16284748780-1d6a99b39-c1dd-a426-e053-dadaa90af4c2f7d9d723-e821-4d1b-a22a-9d7023029f0f
78658-001-052022-01-28C16284748780-1d6a99b39-c1dd-a426-e053-dadaa90af4c2f7d9d723-e821-4d1b-a22a-9d7023029f0f
78658-001-062022-01-28C16284748780-1d6a99b39-c1dd-a426-e053-dadaa90af4c2f7d9d723-e821-4d1b-a22a-9d7023029f0f
78658-001-072022-01-28C16284748780-1d6a99b39-c1dd-a426-e053-dadaa90af4c2f7d9d723-e821-4d1b-a22a-9d7023029f0f
78658-001-082022-01-28C16284748780-1d6a99b39-c1dd-a426-e053-dadaa90af4c2f7d9d723-e821-4d1b-a22a-9d7023029f0f
78658-001-092022-01-28C16284748780-1d6a99b39-c1dd-a426-e053-dadaa90af4c2f7d9d723-e821-4d1b-a22a-9d7023029f0f
78658-001-102022-01-28C16284748780-1d6a99b39-c1dd-a426-e053-dadaa90af4c2f7d9d723-e821-4d1b-a22a-9d7023029f0f
78658-001-112022-01-28C16284748780-1d6a99b39-c1dd-a426-e053-dadaa90af4c2f7d9d723-e821-4d1b-a22a-9d7023029f0f
78658-001-122022-01-28C16284748780-1d6a99b39-c1dd-a426-e053-dadaa90af4c2f7d9d723-e821-4d1b-a22a-9d7023029f0f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78658-001-01Champ30 mL in 1 BOTTLE, PLASTICGEL301
78658-001-02Champ59 mL in 1 BOTTLE, PLASTICGEL591
78658-001-03Champ104 mL in 1 BOTTLE, PLASTICGEL1041
78658-001-04Champ118 mL in 1 BOTTLE, PLASTICGEL1181
78658-001-05Champ177 mL in 1 BOTTLE, PLASTICGEL1771
78658-001-06Champ236 mL in 1 BOTTLE, PLASTICGEL2361
78658-001-07Champ296 mL in 1 BOTTLE, PLASTICGEL2961
78658-001-08Champ473 mL in 1 BOTTLE, PLASTICGEL4731
78658-001-09Champ1000 mL in 1 BOTTLE, PLASTICGEL10001
78658-001-10Champ3785 mL in 1 BOTTLE, PLASTICGEL37851
78658-001-11Champ208198 mL in 1 BOTTLE, PLASTICGEL2081981
78658-001-12Champ1040990 mL in 1 BOTTLE, PLASTICGEL10409901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78658-001CHAMP (ALCOHOL) GEL [CHAMP PRODUCTS, LTD]1Legacy NDC, 12 package rows20200604_f7d9d723-e821-4d1b-a22a-9d7023029f0f.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78658-00178658-001-01, 78658-001-02, 78658-001-03, 78658-001-04, 78658-001-05, 78658-001-06, 78658-001-07, 78658-001-08, 78658-001-09, 78658-001-10, 78658-001-11, 78658-001-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
GLYCERINPDC6A3C0OXIACT
GUARAPROLOSE (3500 MPA.S AT 1%)3A1I7376TCIACT
FRAGRANCE LAVENDER & CHIA F-153480SXS9CO2TZKIACT

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
6ff97ece-90df-4e1f-a488-894ed9d34ee3f7d9d723-e821-4d1b-a22a-9d7023029f0f2020-05-08WarningsExact identifier
spl id: 6ff97ece-90df-4e1f-a488-894ed9d34ee3
spl set id: f7d9d723-e821-4d1b-a22a-9d7023029f0f

Reported adverse events (FAERS/openFDA)#

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