75% ALCOHOL HAND SANITIZER- alcohol gel

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)

Commercializzato da:

Narwhal, Inc.

Via di somministrazione:

TOPICAL

Tipo di ricetta:

OTC DRUG

Indicazioni terapeutiche:

Antiseptic. Hand senitizer Hand sanitizer to help decrease bacteria on the skin when water, soap, and towel are not available. Recommended for repeated use. Do not apply around eyes. Do not use in ears & mouth. Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

Stato dell'autorizzazione:

OTC monograph not final

Scheda tecnica

75% ALCOHOL HAND SANITIZER- ALCOHOL GEL
NARWHAL, INC.
_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._
----------
75% ALCOHOL HAND SANITIZER
ACTIVE INGREDIENT
Alcohol 75% v/v. Purpose: Antiseptic
PURPOSE
Antiseptic. Hand senitizer
USES
Hand sanitizer to help decrease bacteria on the skin when water, soap,
and towel are
not available. Recommended for repeated use.
DIRECTIONS
Place enough product into your palms and thoroughly spread on both
hands.
Rub into skin until dry.
Children under 6 years old must be supervised using this product.
Avoid contact with eyes; in case of contact, flush with water.
WARNINGS
For external use only.
Flammable. Keep away from fire or flame.
Do not apply around eyes. Do not use in ears & mouth.
Stop use and ask a doctor if redness or irritation develop and persist
for more than 72
hours.
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or
contact a Poison
Control Center immediately.
INACTIVE INGREDIENTS
Carbomer, triethanolamine, glycerin, water
Store below 110°F (43°C). May discolor certain fabrics or surfaces.
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL
237 mL NDC: 78615-001-01
500 mL NDC: 78615-001-02
1000 mL NDC: 78615-001-03
Narwhal, Inc.
75% ALCOHOL HAND SANITIZER
alcohol gel
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:78615-001(NDC:74621-010)
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
ALCOHOL
75 mL in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ACRYLIC ACID (UNII: J94PBK7X8S)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:78615-
001-01
237 mL in 1 BOTTLE; Type 0: Not a Combination
Product
06/01/2020
2
NDC:78