ROYAL PETROLEUM (VITAMIN E ENRICHED)- petrolatum jelly

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Filo America

INN (International Name):

PETROLATUM

Composition:

PETROLATUM 30 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Skin Protectant Temporarily protects minor: cuts  scrapes  burns Temporarily protects and helps relieve chapped or cracked skin Helps protect from the drying effects of wind and cold weather Stop use and ask doctor if condition worsens, Symptoms last more than 7 days clear up and occur again within a few days.

Authorization status:

OTC monograph final

Summary of Product characteristics

ROYAL PETROLEUM (VITAMIN E ENRICHED)- PETROLATUM JELLY
FILO AMERICA
_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._
----------
DRUG FACT
Creamy petroleum Jelly is specially formulated to moisturize, soften
and soothe dry skin. Blended with
Vitamin E to produce a rich creamy moisturizer. Use on hands, knees,
feet and heels to smooth away
dryness. Great for moisturizing face and neck.
DRUG FACTS
Active Ingredient Purpose
Petrolatum 30% Skin Protectant
Purpose
Skin Protectant
Temporarily protects minor: cuts scrapes burns
Temporarily protects and helps relieve chapped or cracked skin
Helps protect from the drying effects of wind and cold weather
Warnings
For external use only. Do not use on deep puncture wounds.
When using this product, do not get into eyes
Stop use and ask doctor if condition worsens, Symptoms last more than
7 days clear up and occur again
within a few days.
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center right
away.
Directions: apply as needed
Inactive ingredients:
water (Aqua), Carbopol 940, Stearic Acid, Glyceryl Monostearate,
Mineral Oil, Cetearyl Alcohol,
GE125 Emulsifying Agent, Methylparaben, Propyparaben, Triethanolamine,
Tocopheryl Acetate, Cocoa
Butter, Fragrance.
*This product is not manufactured or distributed by Unilever,
distributor of the registered trademark
Vaseline (r)
MADE IN CHINA
DISTRIBUTED BY:
Filo America
P.O. Box 23592
Los Angeles, CA 90023
Questions or Concerns?
1.866.460.0322
ROYAL PETROLEUM (VITAMIN E ENRICHED)
petrolatum jelly
Filo America
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:50 438 -40 1
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
30 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE N