FLORAL FRENZY - ethyl alcohol gel
Shanghai Weierya Daily Chemicals Factory

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

Inactive Ingredients

carbomer 940,

PEG-12 dimethicone,

propylene glycol,

tocopheryl acetate,

triethanolamine,

water

Active Ingredient

Ethyl Alcohol 65 % v/v

Purpose Antimicrobial

Warnings

For external use only.

Keep out of reach of children. If swallowed,

get medical help or contact a Poison

Control Center right away.

Uses

hand sanitizer to help reduce bacteria on skin

Directions Put a dime sized drop onto hands

and rub together briskly until dry.

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.

Flammable. Keep away from

fire or flame.

Other Information

Store below 110 F ( 43 C )

copy of label

FLORAL FRENZY
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58194-027
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58194-027-01	29 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/03/2015

Labeler - Shanghai Weierya Daily Chemicals Factory (420359333)

Name	Address	ID/FEI	Business Operations
Establishment
Shanghai Weierya Daily Chemicals Factory		420359333	manufacture(58194-027)

Revised: 7/2015

Document Id: 8ef1908d-5835-4a19-9640-472be2885b2b

Set id: e9c0e11d-d869-4fbd-837a-8b1dbcb50613

Version: 1

Effective Time: 20150703

Shanghai Weierya Daily Chemicals Factory