BIOMEDISUN HAND SANITIZER- alcohol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PL COSMETIC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph not final

Summary of Product characteristics

BIOMEDISUN HAND SANITIZER- ALCOHOL GEL
PL COSMETIC
_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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[BIOMEDISUN] 100 ML TUBE TYPE 62: 74339-4162
PL COSMETIC
BIOMEDISUN HAND SANITIZER
alcohol gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:74339 -416 2
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
6 2 mL in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
GLYCERIN (UNII: PDC6 A3C0 OX)
CARBO MER HO MO PO LYMER, UNSPECIFIED TYPE (UNII: 0 A5MM30 7FC)
WATER (UNII: 0 59 QF0 KO0 R)
BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)
HYALURO NATE SO DIUM (UNII: YSE9 PPT4TH)
TRO LAMINE (UNII: 9 O3K9 3S3TK)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:74339 -416 2-1
10 0 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct
0 3/31/20 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 3/31/20 20
LABELER -
PL COSMET IC (688393375)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
PL COSMETIC
6 8 8 39 3375
ma nufa c ture (74339 -416 2)
Revised: 4/2020