ANTISEPTIC WIPES- ethyl alcohol cloth

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Ethyl Alcohol 62%........ Antiseptic

Available from:

Flex Beauty Labs

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic Decresases bacteria on skin Do not use if you are allegic to any of the ingredients. Stop use and ask a doctor if irritation or redness develops and continues for more than 72 hours.

Authorization status:

OTC monograph not final

Summary of Product characteristics

ANTISEPTIC WIPES- ETHYL ALCOHOL CLOTH
FLEX BEAUTY LABS
_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._
----------
GERM OUT WET WIPES ALCOHOL WIPES
ACTIVE INGREDIENTS
Ethyl Alcohol 62%........ Antiseptic
PURPOS E
Antiseptic
US E
Decresases bacteria on skin
WARNINGS
FOR EXTERNAL USE ONLY
DO NOT USE
Do not use if you are allegic to any of the ingredients.
WHEN USING THIS PRODUCT
When using this product do not use in or near eyes.
In cases of contact, rinse eyes thoroughly with water.
STOP USE AND ASK A DOCTOR IF
Stop use and ask a doctor if irritation or redness develops and
continues for more than 72 hours.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away
DIRECTIONS :
Adults and children over 2 yeas of age:Apply to hands. Allow to dry
without wioing.
Children under 2 year of age:ask doctor before use
INACTIVE INGREDIENTS
Aloe barbadensis Extract, Fragrance, Glycerin, Lactic Acid, Water
PRINCIPAL DISPLAY PANEL
ANTISEPTIC WIPES
ethyl alcohol cloth
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:7230 8 -0 29
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)
ALCOHOL
6 2 mg in 10 0 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
GLYCERIN (UNII: PDC6 A3C0 OX)
ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)
LACTIC ACID, UNSPECIFIED FO RM (UNII: 33X0 4XA5AT)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END DATE
1
NDC:7230 8 -0 29 -
18
18 in 1 PACKAGE
0 8 /0 3/20 20
1
6 2 mg in 1 PACKET; Type 1: Co nvenience Kit o f Co -
Pa c ka ge
Flex Beauty Labs
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph no t final
pa rt333A