BABY BUM HAND SANITIZER- alcohol liquid

Baby Bum Hand Sanitizer by

Drug Labeling and Warnings

Baby Bum Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Sun Bum LLC, Formulated Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl alcohol 62%

Purpose

Antiseptic

Uses

• to help reduce bacteria on the skin
• recommended for repeated use

Warnings

For external use only

Flammable keep away from fire or flame

When using this product

do not use in or near the eyes. In case of eye contact, rinse thoroughly with water.

Stop use and ask a doctor if 

irritation or rash appears and lasts. Condition persists for more than 72 hours

Keep out of reach of children.

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

Directions

• spray enough product in your palms to thoroughly cover your hands 
• rub hands together briskly until dry
• children under 6 years of age should be supervised when using this product

Other information

• do not store above 104° F/40°C
• may discolor some fabrics or surfaces

Inactive ingredients

water,fragrance,glycerin,aloe barbadensis leaf juice, cucumis sativus (cucumber) fruit extract, musa sapientum (banana) fruit extract, hedychium coronarium root extract, gardenia taitensis flower extract, cocos nucifera (coconut) oil, sea salt, ethylhexylglycerin

Questions?

1-877-978-6286

Package Labeling:

INGREDIENTS AND APPEARANCE

BABY BUM HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-614
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CUCUMBER (UNII: YY7C30VXJT)
BANANA (UNII: 4AJZ4765R9)
HEDYCHIUM CORONARIUM ROOT (UNII: 92A6N0IQN9)
GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)
COCONUT OIL (UNII: Q9L0O73W7L)
SEA SALT (UNII: 87GE52P74G)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-614-01	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/01/2020

Labeler - Sun Bum LLC (028642574)

Establishment
Name	Address	ID/FEI	Business Operations
Formulated Solutions, LLC		143266687	manufacture(69039-614)