Tendersant Hand Sanitizer — v3

Tendersant Hand Sanitizer

7 Views

Version

v3

Effective date

September 23, 2025

Original packager

Yes

Sections captured

12

Identifiers

Document ID
3f7b3095-d1c2-4f15-e063-6394a90a50aa
Set ID
b09d568a-4c9d-5804-e053-2a95a90ab8ea
Application numbers
505G(a)(3)
Product NDCs
69771-007
Package NDCs
69771-007-01, 69771-007-02, 69771-007-03
Original packager NDCs
—

Names & Manufacturers

Brand names
Tendersant Hand Sanitizer
Generic names
ALCOHOL
Manufacturer names
Geri-Gentle Corporation
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
ALCOHOL
Routes
TOPICAL
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
—
Pharmacologic class (CS)
—
Mechanism of action
—

Other identifiers

NUI
—
RxCUI
581662
UNII
3K9958V90M
UPC
0648289153057, 0648289153101, 0648289153156

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient Ethyl Alcohol 70% Purpose Antiseptic
Dosage And Administration (1)

Sequence 1

Directions: Not recommended for infants Wet hands thoroughly with product and allow to dry without wiping Children under 6 years of age should be supervised when using this product.
Inactive Ingredient (1)

Sequence 1

Inactive ingredients: Water, Aloe Barbadensis Leaf Juice, Maltodextrin, Glycerin, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate crosspolymer, Triethanolamine, Fragrance.
Indications And Usage (1)

Sequence 1

Uses: To decrease bacteria on the skin. Recommended for repeated use.
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children If swallowed, get medical help
Package Label Principal Display Panel (3)

Sequence 1

Package Labeling:118ml Label

Sequence 2

Package Labeling:500ml Label

Sequence 3

Package Labeling:236ml Label
Purpose (1)

Sequence 1

Purpose Antiseptic
Spl Product Data Elements (1)

Sequence 1

Tendersant Hand Sanitizer ALCOHOL WATER ALOE VERA LEAF MALTODEXTRIN GLYCERIN PROPYLENE GLYCOL CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) TROLAMINE ALCOHOL ALCOHOL
Spl Unclassified Section (2)

Sequence 1

Drug Facts

Sequence 2

Other information: Do not store above 110°F, May discolor some fabrics..
Stop Use (1)

Sequence 1

Stop use: if irritation or redness develops. If condition persists for more than 72 hours consult a doctor.
Warnings (1)

Sequence 1

Warnings Keep away from fire or flame. Flammable. Avoid contact with broken skin. For external use only. When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water Stop use: if irritation or redness develops. If condition persists for more than 72 hours consult a doctor. Keep out of reach of children If swallowed, get medical help
When Using (1)

Sequence 1

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water

OpenFDA raw payload

{'application_number': ['505G(a)(3)'],
 'brand_name': ['Tendersant Hand Sanitizer'],
 'generic_name': ['ALCOHOL'],
 'is_original_packager': [True],
 'manufacturer_name': ['Geri-Gentle Corporation'],
 'package_ndc': ['69771-007-01', '69771-007-02', '69771-007-03'],
 'product_ndc': ['69771-007'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'rxcui': ['581662'],
 'spl_id': ['3f7b3095-d1c2-4f15-e063-6394a90a50aa'],
 'spl_set_id': ['b09d568a-4c9d-5804-e053-2a95a90ab8ea'],
 'substance_name': ['ALCOHOL'],
 'unii': ['3K9958V90M'],
 'upc': ['0648289153057', '0648289153101', '0648289153156']}