CAMPHOR gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)

Available from:

Chemco Corporation

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph not final

Summary of Product characteristics

CAMPHOR- CAMPHOR 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._
----------
49283-331-04
CAMPHOR
camphor gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:49 28 3-331
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2) (ISOPROPYL ALCOHOL -
UNII:ND2M416 30 2)
ISOPROPYL
ALCOHOL
9 4.8 mL
in 9 9 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
EUCALYPTUS GLO BULUS LEAF (UNII: S546 YLW6 E6 )
WATER (UNII: 0 59 QF0 KO0 R)
MENTHA ARVENSIS LEAF O IL (UNII: 1AEY1M553N)
PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)
O LETH-2 0 (UNII: YTH16 7I2AG)
MENTHO L (UNII: L7T10 EIP3A)
CARBO MER 9 4 0 (UNII: 4Q9 3RCW27E)
FD&C BLUE NO . 1 (UNII: H3R47K3TBD)
DIPRO PYLENE GLYCO L MO NO CAPRATE MO NO CAPRYLATE (UNII: 59 8 0 W9 79
EL)
METHYLPARABEN (UNII: A2I8 C7HI9 T)
DMDM HYDANTO IN (UNII: BYR0 546 TOW)
SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)
PRODUCT CHARACTERISTICS
COLOR
S CORE
S HAP E
S IZ E
FLAVOR
IMPRINT CODE
CONTAINS
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:49 28 3-331-28
378 5 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
0 6 /11/20 20
2
NDC:49 28 3-331-0 5 18 9 27 mL in 1 PAIL; Type 0 : No t a Co mbinatio
n Pro duct
0 6 /23/20 20
3
NDC:49 28 3-331-0 4 118 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n
Pro duct
0 6 /23/20 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 6 /11/20 20
LABELER -
Chemco Corporation (032495954)
REGISTRANT -
Chemco Corporation (032495954)
ESTABLISHMENT
Chemco Corporation
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 3-331)
Revised: 6/2020