ALCOHOL gel ALCOHOL liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Pop Fizz Designs

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph not final

Summary of Product characteristics

ALCOHOL- ALCOHOL GEL
ALCOHOL- ALCOHOL LIQUID
POP FIZZ DESIGNS
_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._
----------
SANITIZER GEL
DRUG FACTS
ACTIVE INGREDIENT
Ethyl Alcohol 62%
PURPOSE
Antiseptic
USES
To help reduce bacteria on the skin.
WARNINGS
For external use only. Flammable. Keep away from fire or flame. Stop
use and ask
doctor if irritation or rash appears.
KEEP OUT OF THE REACH OF CHILDREN
If swallowed, get medical help.
DIRECTIONS
Pump as needed into the palm of hands. Rub hands together quickly
until dry. Children
under 6 years old should be supervised when using this product.
OTHER INFORMATION
Store below 118°F
INACTIVE INGREDIENTS
Water, Aloe Barbendensis Leaf Juice, Maltodextrin, Glycerin, Propylene
Glycol,
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethonoamine,
Fragrance, FD&C Blue
No. 1, D&C Red No. 33.
ALCOHOL
alcohol gel
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:73884-002
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
ALCOHOL
62 mL in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII:
71DD5V995L)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TROLAMINE (UNII: 9O3K93S3TK)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:73884-002-
12
10 in 1 BOX
09/20/2022
1
NDC:73884-002-
02
29 mL in 1 BOTTLE; Type 0: Not a Combination
Product
2
NDC:73884-002-
13
10 in 1 BOX
09/20/2022
2
NDC:73884-002-
03
29 mL in 1 BOTTLE; Type 0: Not a Combination
Product
3
NDC:73884-002-
14
10 in 1 BOX
09/20/2022
3
NDC:73884-002-
04
2