LITTLE BUDDY IN A LITTLE TUBBY- hand sanitizing towelettes cloth

Little Buddy in a Little Tubby by

Drug Labeling and Warnings

Little Buddy in a Little Tubby by is a Otc medication manufactured, distributed, or labeled by Continental Research Corp, Athea Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Benzalkonium chloride 0.12%

Purpose

Antiseptic

Use

For handwashing to decrease bacteria on the skin. After changing diapers. After assisting ill persons. Before contact with a person under medical care or treatment. Recommended for repeat use.

Warnings

For external use only.

Do not use

Do not use in the eyes.

WHEN USING

When using this product do not get into eyes. If contact occurs, rinse thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hands thoroughly with product and allow to dry. Children under six years of age should be

supervised when using this product.

Other information

Store in a cool, dry place.

Inactive ingredients

Water, Aloe Barbadensis Leaf Juice, Polysorbate 20, Glycerin, Potassium Sorbate, Fragrance, Citric Acid, Disodium EDTA, Tocopheryl Acetate (Vitamin E).

Package Label - Principal Display Panel

70 PCS NDC: 64321-123-70

INGREDIENTS AND APPEARANCE

LITTLE BUDDY IN A LITTLE TUBBY 
hand sanitizing towelettes cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64321-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.12 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64321-123-70	70 in 1 CANISTER	02/18/2023
1		70 mL in 1 CANISTER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/18/2023

Labeler - Continental Research Corp (071988653)

Establishment
Name	Address	ID/FEI	Business Operations
Athea Laboratories Inc		006117816	manufacture(64321-123)