assured™

assured™
SPL v1
SPL
SPL Set ID 91f24a0c-276f-4962-8da8-462b1f42040e
Route
topical
Published
Effective Date 2019-05-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
petrolatum (30 g)
Inactive Ingredients
water glycerin glyceryl monostearate peg-100 stearate stearic acid polyoxyl 20 cetostearyl ether trolamine lanolin alcohols carbomer copolymer type a (allyl pentaerythritol crosslinked) phenoxyethanol triethylene glycol cocoa butter .alpha.-tocopherol acetate edetate disodium

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2019-05-17

Purpose

Skin protectant

Description

White Petrolatum USP (30 %)


Medication Information

Warnings

For external use only.

Do not use on deep puncture wounds, animal bites and serious burns.

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
Purpose

Skin protectant

Directions

apply as needed.

Inactive Ingredients

water (aqua), glycerin, glyceryl monostearate, PEG-100 stearate, stearic acid, ceteareth 20, trieathanolamine, lanolin alcohol, fragrance, acrylates/C 10-30 alkyl acrylate crosspolymer, phenoxyethanol, triethylene glycol, cocoa butter, tocopheryl acetate, disodium EDTA

110781 DISTRIBUTED BY

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY,

CHESAPEAKE, VA 23320

MADE IN INDIA

Skin Softener

Hydrates &

Evens Skin Tone

COCOA

BUTTER

Petroleum Jelly

C. No. DNH/COS/DNH/130

1222101976

Description

White Petrolatum USP (30 %)

Active Ingredient:

White Petrolatum USP (30 %)

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.

Principal Display Panel 3 Oz Tube Label

ASSURED™

Vitamin E Enriched

Creamy

COCOA

BUTTER

Petroleum Jelly

Skin Softener

Hydrates &

Evens Skin Tone

Net Wt 3 oz (85g)

NDC # 33992-0498-1


Structured Label Content

Warnings

For external use only.

Do not use on deep puncture wounds, animal bites and serious burns.

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
Purpose

Skin protectant

Directions

apply as needed.

Inactive Ingredients (Inactive ingredients)

water (aqua), glycerin, glyceryl monostearate, PEG-100 stearate, stearic acid, ceteareth 20, trieathanolamine, lanolin alcohol, fragrance, acrylates/C 10-30 alkyl acrylate crosspolymer, phenoxyethanol, triethylene glycol, cocoa butter, tocopheryl acetate, disodium EDTA

110781 DISTRIBUTED BY

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY,

CHESAPEAKE, VA 23320

MADE IN INDIA

Skin Softener

Hydrates &

Evens Skin Tone

COCOA

BUTTER

Petroleum Jelly

C. No. DNH/COS/DNH/130

1222101976

Active Ingredient:

White Petrolatum USP (30 %)

When Using This Product, (When using this product,)

do not get into eyes

Stop Use and Ask Doctor If (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. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Principal Display Panel 3 Oz Tube Label (Principal Display Panel - 3 oz Tube Label)

ASSURED™

Vitamin E Enriched

Creamy

COCOA

BUTTER

Petroleum Jelly

Skin Softener

Hydrates &

Evens Skin Tone

Net Wt 3 oz (85g)

NDC # 33992-0498-1


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)