HYDROLATUM- white petrolatum cream

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Denison Pharmaceuticals, LLC

관리 경로:

TOPICAL

처방전 유형:

OTC DRUG

치료 징후:

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

승인 상태:

OTC monograph final

제품 특성 요약

HYDROLATUM- WHITE PETROLATUM CREAM
DENISON PHARMACEUTICALS, LLC
----------
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 [e-mail]
deep or punctured wounds
animal bites
serious burns
Keep out of reach of children
HYDROLATUM
white petrolatum cream
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:0295-9011
Denison Pharmaceuticals, LLC
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)
PETROLATUM
45 g in 100 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:0295-9011-
13
57 g in 1 TUBE; Type 0: Not a Combination
Product
02/19/2020
2
NDC:0295-9011-
36
454 g in 1 JAR; Type 0: Not a Combination
Product
02/19/2020
3
NDC:0295-9011-
69
340 g in 1 JAR; Type 0: Not a Combination
Product
09/12/2022
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC Monograph Drug
M016
02/19/2020
LABELER -
Denison Pharmaceuticals, LLC (001207208)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Denison Pharmaceuticals, LLC
001207208
manufacture(0295-9011)
Revised: 10/2023