NE MEXICO AGING LONG TERM SERVICES DEPARTMENT HAND SANITIZER- benzalkonium chloride gel

Ne Mexico Aging Long Term Services Department Hand Sanitizer by

Drug Labeling and Warnings

Ne Mexico Aging Long Term Services Department Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Sombra Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Benzalkonium Chloride 0.15%

Uses

To decrease bacteria and viruses on the skin that could cause disease. Recommended for repeated use.

Warnings

For external use only: hands.

Do Not Use

avoid contact with broken skin. Do not inhale or ingest. Children under 6, use only
under adult supervision. Not recommended for infants.

When Using

When using this product, keep out of the eyes. In case of contact with eyes, flush thoroughly with water.

Stop Use

Stop use if irritation and redness develop or if condition persists for more than 72 hours.

Keep out of reach of childrenn

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

Directions

Wet hands thoroughly with product and allow to dry without wiping. For children inder 6, use only under adult supervision.

Storage and Handling

Store away from oxidizing agents. Do not store above 100 C.

Inactive ingredients

Purified water, glycerin, cyamopsis tetragonoloba (Guar) gum, citrus limon (lemon) peel oil, hamamelis virginiana (witch hazel) leaf extract, camellia sinensis (green tea) leaf extract, champmilla recutita (matricaria) flower extract, rosa damascena (rose) flower waterr, aloe barbadensis leaf juice, yucca schidigera stem extract, filipendula ulmaria (queen of the prairie) extract, phenoxyethanol, caprylyl glyol, citric acid

Purpose

Anitmicrobial

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NE MEXICO AGING LONG TERM SERVICES DEPARTMENT HAND SANITIZER 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61577-4200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GUAR GUM (UNII: E89I1637KE)
LEMON OIL (UNII: I9GRO824LL)
WITCH HAZEL (UNII: 101I4J0U34)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ROSA DAMASCENA FLOWER (UNII: JWB78P295A)
CHAMOMILE (UNII: FGL3685T2X)
YUCCA SCHIDIGERA STEM (UNII: N59C6T6D72)
FILIPENDULA RUBRA WHOLE (UNII: MT26BL24AZ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61577-4200-8	237 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/03/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/03/2021

Labeler - Sombra Cosmetics (097464309)

Establishment
Name	Address	ID/FEI	Business Operations
Sombra Cosmetics		097464309	manufacture(61577-4200)