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.

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New Mexico Aging Long-Term Services Department Alcohol Free Hand Sanitizer

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

NE MEXICO AGING LONG TERM SERVICES DEPARTMENT HAND SANITIZER 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-4200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61577-4200-8237 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/03/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/03/2021
Labeler - Sombra Cosmetics (097464309)
Establishment
NameAddressID/FEIBusiness Operations
Sombra Cosmetics097464309manufacture(61577-4200)

Revised: 9/2021
Document Id: fce28333-43cb-49ac-be61-8b4f811f92ff
Set id: 34b0fc65-ca2a-4ac4-bbe3-ccb3d9c0a851
Version: 1
Effective Time: 20210903
 
Sombra Cosmetics