UNIVERSITY OF MICHIGAN- hand sanitizer gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Double Body Biotech Limited

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic - Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. - If irritation or rash occurs. These may be signs of a serious condition. - In children less than 2 months of age. - On open skin wounds.

Authorization status:

OTC monograph not final

Summary of Product characteristics

UNIVERSITY OF MICHIGAN- HAND SANITIZER GEL
DOUBLE BODY BIOTECH 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._
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UNIVERSITY OF MICHIGAN HAND SANITIZER
ACTIVE INGREDIENT
Alcohol 75%
PURPOS E
Antiseptic
US E
Hand Sanitizer to help reduce bacteria that potentially can cause
disease. For use when soap and
water are not available.
WARNINGS
FOR EXTERNAL USE ONLY.
FLAMMABLE. KEEP AWAY FROM HEAT OR FLAME.
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.
DO NOT USE
In children less than 2 months of age.
On open skin wounds.
DIRECTIONS
Wet hands thoroughly with gel, rub vigorously and allow to dry without
wiping.
Children under 6 years of age should be supervised when using this
product.
OTHER INFORMATION
Store below 106 F(41 )
INACTIVE INGREDIENTS
Water, Glycereth-26, Carbomer, Sodium Hydroxide, Aloe Barbadensis Leaf
Extract
UNIVERSITY OF MICHIGAN
hand sanitizer gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:746 57-0 16
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Double Body Biotech Limited
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
75 mL in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)
GLYCERETH-2 6 (UNII: NNE56 F2N14)
CARBO MER 9 8 0 (UNII: 4Q9 3RCW27E)
ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)
WATER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:746 57-0 16 -0 1
59 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
0 7/0 8 /20 20
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DA