MNFR SAFE by SOMBRA COSMETICS MNFR SAFE- alcohol gel

MNFR SAFE by

Drug Labeling and Warnings

MNFR SAFE by is a Otc medication manufactured, distributed, or labeled by SOMBRA COSMETICS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Ethyl Alcohol 70%

Purpose

Antiseptic, Hand Sanitizer

Uses

Helps reduce bacteria on the skin that could cause diseases.

Warnings

Flammable. Keep fire or flame. For external use only.

Do not use

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

WHEN USING

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

STOP USE

Stop use and ask a doctor if irritation or rash appears and lasts.

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

Place enough product in the palm of your hands to thoroughly cover your hands. Rub hands together briskly until product is completely absorbed and hands are dry.

Other information

• Store between 15-30C (59-86F)
  Avoid freezing and excessive heat above 40C (105F)

Inactive ingredients

glycerin, purified water, carbomer, aminomethyl propanol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MNFR SAFE 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61577-1115
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61577-1115-8	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/30/2020
2	NDC: 61577-1115-1	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/22/2020

Labeler - SOMBRA COSMETICS (097464309)

Establishment
Name	Address	ID/FEI	Business Operations
SOMBRA COSMETICS		097464309	manufacture(61577-1115) , label(61577-1115)