ETHYL ALCOHOL gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Chemco Corporation

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph not final

Summary of Product characteristics

ETHYL ALCOHOL- ETHYL ALCOHOL GEL
CHEMCO CORPORATION
_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._
----------
49283-700-64
ETHYL ALCOHOL
ethyl alcohol gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:49 28 3-70 0
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
70 mL in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6 O37OK2I)
BUTYLPHENYL METHYLPRO PIO NAL (UNII: T7540 GJV6 9 )
ISO METHYL-.ALPHA.-IO NO NE (UNII: 9 XP4LC555B)
WATER (UNII: 0 59 QF0 KO0 R)
Chemco Corporation
GLYCERIN (UNII: PDC6 A3C0 OX)
PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)
CARBO MER 9 4 0 (UNII: 4Q9 3RCW27E)
TRO LAMINE (UNII: 9 O3K9 3S3TK)
ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)
ALPHA-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )
BENZYL SALICYLATE (UNII: WAO5MNK9 TU)
LINALO O L, ( +/-) - (UNII: D8 1QY6 I8 8 E)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE MARKETING END DATE
1
NDC:49 28 3-70 0 -6 4 18 9 2 mL in 1 BOTTLE; Type 0 : No t a Co
mbinatio n Pro duct
0 9 /0 8 /20 20
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
0 9 /0 8 /20 20
LABELER -
Chemco Corporation (032495954)
REGISTRANT -
Chemco Corporation (032495954)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
Chemco Co rpo ratio n
0 3249 59 54
ma nufa c ture (49 28 3-70 0 )
Revised: 9/2020