Ne Mexico Aging Long Term Services Department Hand Sanitizer: Package Insert and Label Information

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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

New Mexico Aging and Long Term Services Hand Sanitizer
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.15 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
CITRIC ACID MONOHYDRATE
GUAR GUM
LEMON OIL
WITCH HAZEL
ALOE VERA LEAF
ROSA DAMASCENA FLOWER
CHAMOMILE
YUCCA SCHIDIGERA STEM
FILIPENDULA RUBRA WHOLE
GREEN TEA LEAF
PHENOXYETHANOL
CAPRYLYL GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61577-4200-8 237 g in 1 BOTTLE, PLASTIC None
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 Operations
Sombra Cosmetics 097464309 manufacture (61577-4200)

Revised: 09/2021 Sombra Cosmetics

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