HYDROLATUM- white petrolatum cream

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

इसे खरीदें

सक्रिय संघटक:

PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)

थमां उपलब्ध:

Denison Pharmaceuticals, LLC

प्रशासन का मार्ग:

TOPICAL

प्रिस्क्रिप्शन प्रकार:

OTC DRUG

चिकित्सीय संकेत:

Skin Protectant - temporarily protects and helps relieve chapped or cracked skin - helps prevent and protect from the drying effects of wind and cold weather - if condition lasts more than 7 days - deep or punctured wounds - animal bites - serious burns

प्राधिकरण का दर्जा:

OTC monograph final

उत्पाद विशेषताएं

                                HYDROLATUM- WHITE PETROLATUM CREAM
DENISON PHARMACEUTICALS, 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._
----------
HYDROLATUM
White Petrolatum, 54%
Skin Protectant
temporarily protects and helps relieve chapped or cracked skin
helps prevent and protect from the drying effects of wind and cold
weather
for external use only
Keep out of reach of children
Stop using if allergic
do not get into eyes
do not get into mouth
if condition lasts more than 7 days
apply as needed
Store at 20-25C (68-77F)
Methylparaben, Purified Water, Sorbitan Sesquioleate
Call Toll Free at 1-800-601-3843 or email complaints@dpharm.net
deep or punctured wounds
animal bites
serious burns
Keep out of reach of children
HYDROLATUM
white petrolatum cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:0 29 5-9 374
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
PETRO LATUM (UNII: 4T6 H12BN9 U) (PETROLATUM - UNII:4T6 H12BN9 U)
PETROLATUM
45 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
SO RBITAN SESQ UIO LEATE (UNII: 0 W8 RRI5W5A)
METHYLPARABEN (UNII: A2I8 C7HI9 T)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
Denison Pharmaceuticals, LLC
1
NDC:0 29 5-9 374-13
57 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct
0 2/19 /20 20
2
NDC:0 29 5-9 374-36
454 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct
0 2/19 /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 final
pa rt346
0 2/19 /20 20
LABELER -
Denison Pharmaceuticals, LLC (001207208)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
Deniso n Pharmaceuticals, LLC
0 0 120 720 8
ma nufa c ture (0 29 5-9 374)
Revised: 7/2020
                                
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