ILEX SKIN PROTECTANT- petrolatum cream

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Denison Pharmaceuticals, LLC

Vartojimo būdas:

TOPICAL

Recepto tipas:

OTC DRUG

Terapinės indikacijos:

Skin Protectant Uses Prevention and treatment of skin irritations and excoriations caused by urinary and fecal material. Can be used on both intact and broken skin. Will adhere to moist weeping wounds. Suitable for adults, children and babies.

Autorizacija statusas:

OTC monograph final

Prekės savybės

ILEX SKIN PROTECTANT- 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._
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ILEX SKIN PROTECTANT PASTE
_ACTIVE INGREDIENT_
White Petrolatum
Skin Protectant
_USES_
Prevention and treatment of skin irritations and excoriations caused
by urinary and fecal material. Can be
used on both intact and broken skin. Will adhere to moist weeping
wounds. Suitable for adults, children
and babies.
WARNINGS
FOR EXTERNAL USE ONLY. Avoid contact with the eyes. Keep out of reach
of children.
KEEP OUT OF REACH OF CHILDREN
_INACTIVE INGREDIENTS_
Calcium / Sodium PVM / MA Copolymers, Corn Starch, Phenoxyethanol and
Isopropyl Isobutyl
Butylparabens, Sodium Carboxymethylcellulose, Zinc Oxide
See directions for use
ILEX SKIN PROTECTANT
petrolatum cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:0 29 5-4271
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
52.2 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
STARCH, CO RN (UNII: O8 232NY3SJ)
BUTYL ESTER O F METHYL VINYL ETHER/MALEIC ANHYDRIDE CO PO LYMER ( 12
50 0 0 MW) (UNII: 38 9 H2R6 2BD)
PHENO XYETHANO L (UNII: HIE49 2ZZ3T)
ISO PRO PYL ISO BUTYRATE (UNII: IB26 71N3UT)
CARBO XYMETHYLCELLULO SE SO DIUM, UNSPECIFIED FO RM (UNII: K6 79
OBS311)
Denison Pharmaceuticals, LLC
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:0 29 5-4271-13
57 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct
0 2/12/20 19
2
NDC:0 29 5-4271-0 1
7 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct
0 2/12/20 19
3
NDC:0 29 5-4271-29
227 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct
0 2/12/20 19
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE