BIODCREAM- zinc oxide cream

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

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Download Vara einkenni (SPC)
23-12-2020

Virkt innihaldsefni:

ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)

Fáanlegur frá:

Advanced Generic Corporation

Stjórnsýsluleið:

TOPICAL

Gerð lyfseðils:

OTC DRUG

Ábendingar:

Skin protectant - helps treat and prevent diaper rash - protects chafed skin due to diaper rash and helps seal out wetness

Leyfisstaða:

OTC monograph final

Vara einkenni

                                BIODCREAM- ZINC OXIDE CREAM
ADVANCED GENERIC 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._
----------
ACTIVE INGREDIENT
Zinc Oxide 15.25%
PURPOS E
Skin protectant
US ES
helps treat and prevent diaper rash
protects chafed skin due to diaper rash and helps seal out wetness
WARNINGS
For external use only.
When using this product avoid contact with eyes.
Stop use and ask doctor if condition worsens or lasts more than 7 days
Keep out of reach of children. If swallowed get medical help or
contact a Poison Control Center
immediately.
DIRECTIONS
Change wet or soiled diaper promptly
Cleanse the diaper area and allow to dry
Apply Cream liberally as often as necessary, with each diaper change,
especially at bedtime or
when exposure to wet diapers may be prolonged.
INACTIVE INGREDIENTS
beeswax, butylated hydroxyl anisole, diazolidinyl urea, lanolin oil,
lavender fragrance, methylparaben,
paraffinum liquidum, propylene glycol, propylparaben, white
petrolatum.
QUESTIONS OR COMMENTS:
1-305-403-3788
BIODCREAM
zinc oxide cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:45737-70 1
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8 SF37)
ZINC CATION
15.25 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
YELLO W WAX (UNII: 2ZA36 H0 S2V)
MINERAL O IL (UNII: T5L8 T28 FGP)
BUTYLATED HYDRO XYANISO LE (UNII: REK49 6 0 K2U)
PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)
DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8 C7HI9 T)
PRO PYLPARABEN (UNII: Z8 IX2SC1OH)
LANO LIN O IL (UNII: OVV5IIJ58 F)
PETRO LATUM (UNII: 4T6 H12BN9 U)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:45737-70 1-0 4
125 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct
0 4/0 1/20 16
MARKETI
                                
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