PAPA MADE- ethyl alcohol 80% liquid

PAPA MADE by

Drug Labeling and Warnings

PAPA MADE by is a Otc medication manufactured, distributed, or labeled by BBIM INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethyl alcohol 80% v/v

Purpose

Antimicrobial

Uses

Hand sanitizer to help reduce bacteria on the skin.

Warnings

Flammable, keep away from fire or flame

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 and ask a doctor

if irritation or rash appears and lasts

Keep out of reach of children.

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

Directions

• spray enough product on your palm to cover hands and rub hands together briskly until dry. 
• children under 6 years of age should be supervised when using Papa Made.

Other information

• Store below 1100C (430F). 
• May discolor certain fabrics or surfaces

Inactive ingredient

Water, Isopropyl Alcohol, Glycerol, Aloe vera, Peppermint oil, Tea tree oil

Product Label

INGREDIENTS AND APPEARANCE

PAPA MADE 
ethyl alcohol 80% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73709-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PEPPERMINT OIL (UNII: AV092KU4JH)
TEA TREE OIL (UNII: VIF565UC2G)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73709-001-01	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333A	03/18/2020

Labeler - BBIM INC (056844846)

Establishment
Name	Address	ID/FEI	Business Operations
BBIM INC		056844846	manufacture(73709-001)