ADVANCED RELIEF A AND D- petrolatum ointment

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Ultra Seal Corporation

Designación común internacional (DCI):

PETROLATUM

Composición:

PETROLATUM 937.5 mg in 1 g

Vía de administración:

TOPICAL

tipo de receta:

OTC DRUG

indicaciones terapéuticas:

Purpose-Skin Protectant Uses-Temporarily protects minor cuts, scrapes, and burns.  Temporarily protects and helps chapped or cracked skin and lips.  Helps protect lips from drying effects of wind and cold weather.

Estado de Autorización:

OTC monograph final

Ficha técnica

ADVANCED RELIEF A AND D- PETROLATUM OINTMENT
ULTRA SEAL 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 (in each gram): White Petrolatum 93.5%
Purpose-Skin Protectant
Uses-Temporarily protects minor cuts, scrapes, and burns. Temporarily
protects and helps chapped or
cracked skin and lips. Helps protect lips from drying effects of wind
and cold weather.
Directions: Apply as needed
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center right
away.
For external use only. Do not use in eyes, on deep puncture wounds,
animal bites, or serious burns or
for more than 1 week unless directed by a doctor.
Stop use and ask a doctor if: A rash or allergic reaction develops.
Condition worsens, persists, or
recurs.
Inactive Ingredients: Corn Oil, Light Mineral Oil, Vitamin A
Palmitate, Vitamin D
ADVANCED RELIEF A AND D
petrolatum ointment
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:42213-375
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
9 37.5 mg in 1 g
INACTIVE INGREDIENTS
Ultra Seal Corporation
INGREDIENT NAME
STRE NG TH
MINERAL O IL (UNII: T5L8 T28 FGP)
CO RN O IL (UNII: 8 470 G57WFM)
VITAMIN A PALMITATE (UNII: 1D1K0 N0 VVC)
ERGO CALCIFERO L (UNII: VS0 41H42XC)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:42213-375-47
144 in 1 CARTON
12/0 1/20 11
1
NDC:42213-375-0 5
5 g in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct
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 rt347
12/0 1/20 11
LABELER -
Ultra Seal Corporation (085752004)
REGISTRANT -
ULT RAtab Laboratories, Inc. (1