NEW NB NATURALLY BOLD NATURAL- hand sanitizer gel gel

NEW NB NATURALLY BOLD by

Drug Labeling and Warnings

NEW NB NATURALLY BOLD by is a Otc medication manufactured, distributed, or labeled by MY PERFUME FACTORY LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

• Put enough product in your palm to cover hands and rub hands together briskly until dry.
• Children under 6 years of age should be supervised when using products.

Other information

• Store below 110°F(43C°)
• Avoid freezing and excessive heat above 40C (104F)
• May discolor certain fabrics or surfaces

Inactive ingredients

Aqua (water), Glycerin, Propylene Glycol, Carbopol, Aminomethyl Propanol, Tocopheryl Acetate

Package Label - Principal Display Panel

50 ml NDC: 78068-123-50

INGREDIENTS AND APPEARANCE

NEW NB NATURALLY BOLD  NATURAL
hand sanitizer gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78068-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78068-123-50	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020
2	NDC: 78068-123-60	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020
3	NDC: 78068-123-61	60 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	05/15/2020
4	NDC: 78068-123-70	70 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020
5	NDC: 78068-123-10	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020
6	NDC: 78068-123-12	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020
7	NDC: 78068-123-25	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020
8	NDC: 78068-123-05	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020
9	NDC: 78068-123-01	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/15/2020

Labeler - MY PERFUME FACTORY LLC (552281933)

Establishment
Name	Address	ID/FEI	Business Operations
MY PERFUME FACTORY LLC		552281933	manufacture(78068-123)