HAND SANITIZER- alcohol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

SKYMAX VIETNAM COMPANY LIMITED

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic, Hand Sanitizer Recommended for repeated use. For handwashing to decrease bacteria on the skin. - in the eyes. In case of contact, rinse eyes thoroughly with water Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Authorization status:

OTC monograph not final

Summary of Product characteristics

HAND SANITIZER- ALCOHOL GEL
SKYMAX VIETNAM COMPANY LIMITED
_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 INGREDIENT(S)
Alcohol 80% v/v. Purpose: Antiseptic
PURPOSE
Antiseptic, Hand Sanitizer
USE
Recommended for repeated use.
For handwashing to decrease bacteria on the skin.
WARNINGS
For external use only. Flammable. Keep away from heat or flame
DO NOT USE
in the eyes. In case of contact, rinse eyes thoroughly with water
Stop use and ask a doctor if irritation and redness 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 right away.
Stop use and ask a doctor if irritation or rash occurs. These may be
signs of a serious
condition.
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control
Center right away.
DIRECTIONS
We hands thoroughly with product
Brisky rub hands together until dry
Supervise children under 6 years in the use of this product.
OTHER INFORMATION
May discolor certain fabrics
Store at the normal temperature
INACTIVE INGREDIENTS
aqua, carbomer 940, trolamine, hydro peroxide, glycerin, fragrance,
vitamin e
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL
100 mL NDC: 81650-100- 01
250 mL NDC: 81650-100- 02
500 mL NDC: 81650-100- 03
1000 mL NDC: 81650-100- 04
HAND SANITIZER
alcohol gel
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:81650-100
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
ALCOHOL
72 mL in 100 mL
SKYMAX VIETNAM COMPANY LIMITED
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
0.02 mL in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)
0.19 mL in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)
0.33 mL in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)
0.15 mL in 10