P B PURE ANTIBACTERIAL HAND SANITIZER OCEAN BREEZE SCENTED- alcohol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

FOURSTAR GROUP USA, INC.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

hand sanitizer to help reduce bacteria on skin

Authorization status:

OTC monograph not final

Summary of Product characteristics

P B PURE ANTIBACTERIAL HAND SANITIZER OCEAN BREEZE SCENTED-
ALCOHOL GEL
FOURSTAR GROUP USA, INC.
----------
P B PURE ANTIBACTERIAL HAND SANITIZER GEL OCEAN BREEZE SCENTED
_DRUG FACTS_
_ACTIVE INGREDIENT_
Ethyl Alcohol, 65% v/v
_PURPOSE_
Antimicrobial
_USES_
hand sanitizer to help reduce bacteria on skin
_WARNINGS_
FOR EXTERNAL USE ONLY.
FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.
DO NOT USE
in or near the eyes In case of contact, rinse eyes thoroughly with
water.
STOP USE AND ASK A DOCTOR IF
irritation, excessive redness or rash develops.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
_DIRECTIONS_
Put a dime sized drop onto hands and rub together briskly until dry.
_OTHER INFORMATION_
Store below 110°F (43°C)
_INACTIVE INGREDIENTS_
water, glycerin, propylene glycol, fragrance, carbomer,
triethanolamine, blue 1
PACKAGE LABELING:
P B PURE ANTIBACTERIAL HAND SANITIZER OCEAN BREEZE
SCENTED
alcohol gel
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:80684-001
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
ALCOHOL
0.65 mL in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PACKAGING
MARKETING START
MARKETING END
FOURSTAR GROUP USA, INC.
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:80684-001-
01
29 mL in 1 BOTTLE; Type 0: Not a Combination
Product
09/24/2020
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC Monograph Drug
505G(a)(3)
09/24/2020
LABELER -
FOURSTAR GROUP USA, INC. (140099503)
Revised: 10/2023