SC HEALTH HAND SANITIZER- alcohol spray, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

SC Health SPV, LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

For hand-washing to decrease bacteria on the skin, only when water is not available.

Authorization status:

OTC monograph not final

Summary of Product characteristics

SC HEALTH HAND SANITIZER- ALCOHOL SPRAY, METERED
SC HEALTH SPV, LLC
_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._
----------
SC HEALTH HAND SANITIZER
DRUG FACTS
ACTIVE INGREDIENT
Alcohol 75%
PURPOSE
Antiseptic
USE
For hand-washing to decrease bacteria on the skin, only when water is
not available.
WARNINGS
Flammable, keep away from fire and flame
For external use only
WHEN USING THIS PRODUCT
Do not get into eyes. If contact occurs, rinse eyes thoroughly with
water.
May discolor some fabrics.
STOP USE AND ASK A DOCTOR IF
Irritation and redness develop.
If swallowed, get medical help or contact a Poison Control Center
right away.
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
wet hands thoroughly with product and allow to dry without wiping.
OTHER INFORMATION
store below 105° F
INACTIVE INGREDIENTS
Water (Aqua), Glycerin, Carbomer, Propylene Glycol, Sodium Hydroxide,
Parfum
(Fragrance), Aloe Barbadensis Leaf Extract.
QUESTIONS?
www.schealth.com
PACKAGE LABELING:
SC HEALTH HAND SANITIZER
alcohol spray, metered
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:78633-003
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
SC Health SPV, LLC
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
ALCOHOL
0.75 mL in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PACKAGING
#
ITEM
CODE
PACKAGE DESCRIPTION
MARKETING
START DATE
MARKETING
END DATE
1
NDC:78633-
003-01
20 mL in 1 BOTTLE, SPRAY; Type 2: Prefilled Drug Delivery
Device/System (syringe, patch, etc.)
08/15/2020
12/31/2022
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START