Xtracare Creamy Petroleum Jelly

Xtracare Creamy Petroleum Jelly
SPL v3
SPL
SPL Set ID 6b765967-aead-4f6d-98ee-fac381a40a6e
Route
TOPICAL
Published
Effective Date 2014-02-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (38 g)
Inactive Ingredients
Water Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Stearic Acid Mineral Oil Cetyl Alcohol Glycerin Polyoxyl 20 Cetostearyl Ether Glyceryl Monostearate Methylparaben Propylparaben Dmdm Hydantoin Trolamine Edetate Sodium Cocoa Butter Fd&c Yellow No. 5 Fd&c Red No. 40 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-02-18

Description

Active Ingredient:                                       Purpose Petrolatum 30% ................................ Skin Protectant


Medication Information

Warnings and Precautions

Warnings

for external use only.

When using this product do not get into eyes.

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Do not use on 

  • deep puncture wounds
  • animal bites
  • serious burns
Indications and Usage

XtraCare® Creamy Petroleum Jelly

Cocoa Butter enriched

Skin Protector

Dry Skin Relief

Rich Creamy Moisturiser

*Compare to the active ingredient in Vaseline® Petroleum Jelly Cream

Net Wt 4.5oz (127g)

Xtracare®

XtraCare Creamy Petroleum Jelly is specially formulated to moisturize, soften and soothe dry skin. Blended with Coco butter oil to product a rich creamy moisturizer. Use on hands, knees, feet and heels to smooth away dryness. Great for moisturizing face and neck.

Dosage and Administration

Directions  apply as needed.

Description

Active Ingredient:                                       Purpose Petrolatum 30% ................................ Skin Protectant

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive Ingredients: 

water, carbomer, stearic acid, mineral oil, cetyl alcohol, glycerin, ceteareth-20, glyceryl monostearate, methylparaben, propylparaben, DMDM hydantoin, triethanolamine, disodium EDTA, theobroma cacao (cocoa) seed butter, fragrance, FD&C yellow no.5, FD&C red no.40, D&C red no.33.

Section 51945-4

Section 55105-1

Uses

  • 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
Section 55106-9

Active Ingredient:                                       Purpose

Petrolatum 30% ................................ Skin Protectant

Section 60561-8

Other information store at room temperature.

Questions/Comments?  1-855-345-5575

*this product is nor manufactured or distributed by UNILEVER, distributor of the registered trademark Vaseline®.

DISTRIBUTED BY

REJOICE INTERNATIONAL INC

NORTHVILLE, MI 48168 USA

MADE IN CHINA


Structured Label Content

Indications and Usage (34067-9)

XtraCare® Creamy Petroleum Jelly

Cocoa Butter enriched

Skin Protector

Dry Skin Relief

Rich Creamy Moisturiser

*Compare to the active ingredient in Vaseline® Petroleum Jelly Cream

Net Wt 4.5oz (127g)

Xtracare®

XtraCare Creamy Petroleum Jelly is specially formulated to moisturize, soften and soothe dry skin. Blended with Coco butter oil to product a rich creamy moisturizer. Use on hands, knees, feet and heels to smooth away dryness. Great for moisturizing face and neck.

Dosage and Administration (34068-7)

Directions  apply as needed.

Warnings and Precautions (34071-1)

Warnings

for external use only.

When using this product do not get into eyes.

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Do not use on 

  • deep puncture wounds
  • animal bites
  • serious burns
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive Ingredients: 

water, carbomer, stearic acid, mineral oil, cetyl alcohol, glycerin, ceteareth-20, glyceryl monostearate, methylparaben, propylparaben, DMDM hydantoin, triethanolamine, disodium EDTA, theobroma cacao (cocoa) seed butter, fragrance, FD&C yellow no.5, FD&C red no.40, D&C red no.33.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses

  • 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
Section 55106-9 (55106-9)

Active Ingredient:                                       Purpose

Petrolatum 30% ................................ Skin Protectant

Section 60561-8 (60561-8)

Other information store at room temperature.

Questions/Comments?  1-855-345-5575

*this product is nor manufactured or distributed by UNILEVER, distributor of the registered trademark Vaseline®.

DISTRIBUTED BY

REJOICE INTERNATIONAL INC

NORTHVILLE, MI 48168 USA

MADE IN CHINA


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