OTC Medication Information: CareALL Creamy Cocoa Butter Petroleum Jelly

CAREALL CREAMY COCOA BUTTER PETROLEUM JELLY- petrolatum cream
New World Imports, Inc

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

White Petrolatum USP

Purpose

Skin Protectant

Uses

  • temporarily protects minor: cuts, scrapes and 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, animal bites and serious burns.

When using this product , do not get into eyes.

Stop use and ask a 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.

Directions

apply as needed.

Inactive Ingredients

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

51824-083-03 Cocoa PJ

CAREALL CREAMY COCOA BUTTER PETROLEUM JELLY
petrolatum cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-083
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PETROLATUM (PETROLATUM) PETROLATUM 30 g in 100 g
Inactive Ingredients
Ingredient Name Strength
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
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51824-083-03 85 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 02/01/2021
Labeler — New World Imports, Inc (075372276)

Revised: 12/2020 New World Imports, Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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