HAND SANITIZER - ethyl alcohol gel
NATIONWIDE PROMOTIONS LLC

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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Drug Facts

Active Ingredient

Ethyl Alcohol

Purpose

Antiseptic

Keep Out of Reach of Children

If swallowed ,get medical help or contact a Poison on Control Center immediately

Use

Decreases bacteria on hands

Warnings

For external use only
Flammable Keep away from fire or flame
Keep out of eyes In case of eye contact immediaterly flush with water and get medical help

Dosage and Administration

Squeeze on to hands and rub hands together briskly until dry

Inactive Ingredients

Deionized Water, Carbomer ,Triethanolamine, Aloe barbadensis Gel, Fragrance Glycerin,
Propylene Glycol,Vitamin E

Product Label

HAND SANITIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58004-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

#	Item Code	Package Description
Packaging
1	NDC:58004-001-01	30 mL in 1 BOTTLE, PLASTIC
2	NDC:58004-001-02	30 mL in 1 BOTTLE, PLASTIC
3	NDC:58004-001-03	30 mL in 1 BOTTLE, PLASTIC
4	NDC:58004-001-04	59 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/27/2013

Labeler - NATIONWIDE PROMOTIONS LLC (792522836)

Name	Address	ID/FEI	Business Operations
Establishment
Yuyao Jessie Commodity Co., Ltd.		529892305	manufacture(58004-001)