SUNY-TIZER- ethyl alcohol gel

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Formology Lab Inc.

Indgivelsesvej:

TOPICAL

Recept type:

OTC DRUG

Terapeutiske indikationer:

ANTISEPTIC TO DECREASE BACTERIA ON THE SKIN THAT POTENTIALLY CAN CAUSE DISEASE

Autorisation status:

OTC monograph not final

Produktets egenskaber

SUNY-TIZER- ETHYL ALCOHOL GEL
FORMOLOGY LAB 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._
----------
SUNY-TIZER, 72580-301
ACTIVE INGREDIENT
ETHYL ALCOHOL 70% V/V
PURPOSE
ANTISEPTIC
USES
TO DECREASE BACTERIA ON THE SKIN THAT POTENTIALLY CAN CAUSE DISEASE
WARNINGS
FOR EXTERNAL USE ONLY.
FLAMMABLE, KEEP AWAY FROM HEAT OR FLAME.
DO NOT USE IN THE EYES.
STOP USE AND ASK A DOCTOR IF IRRITATION OR PAIN OCCURS.
KEEP OUT OF REACH OF CHILDREN.
IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER
RIGHT
AWAY.
DIRECTIONS
APPLY A SUFFICIENT AMOUNT OF PRODUCT TO YOUR PALM TO COVER BOTH
HANDS.
RUB UNTIL DRY.
OTHER INFORMATION
STORE BELOW 110F (43C)
INACTIVE INGREDIENTS
ALOE BARBADENSIS LEAF JUICE, GLYCERIN, HYDROXYETHYLCELLULOSE, CITRUS
LIMON PEEL OIL.
QUESTIONS?
CALL TOLL-FREE 1-833-778-1690 OR VISIT WWW.SUNYTIZER.COM
SUNY-TIZER
ethyl alcohol gel
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:72580-301
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
ALCOHOL
70 mL in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Formology Lab Inc.
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
LEMON OIL (UNII: I9GRO824LL)
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:72580-301-
11
120 mL in 1 BOTTLE; Type 0: Not a Combination
Product
03/13/2020
2
NDC:72580-301-
12
100 mL in 1 BOTTLE; Type 0: Not a Combination
Product
03/13/2020
3
NDC:72580-301-
13
450 mL in 1 BOTTLE; Type 0: Not a Combination
Product
06/28/2020
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph not
final
part333A
03/13/2020
LABELER -