PHARMACYS PRESCRIPTION CREAMY PETROLEUM COCOA BUTTER- petrolatum jelly
NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.

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 Facts
Active ingredient:

Petrolatum 30%

Purpose

Skin Protectant

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.

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.

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), Mineral Oil, Glycerin, Cetearyl Alcohol, Cetyl Alcohol, Stearyl Alcohol, Glyceryl Stearate, Fragrance, Polysorbate 80, Laureth-20, BHT, Methylparaben, Propylparaben, Dimethicone, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate.

label

PHARMACYS PRESCRIPTION CREAMY PETROLEUM COCOA BUTTER
petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76176-122
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	30 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
LAURETH-20 (UNII: 6SU0SC83AH)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
COCOA BUTTER (UNII: 512OYT1CRR)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76176-122-01	127.57 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	01/01/2020

Labeler - NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. (530766098)

Registrant - NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. (530766098)

Name	Address	ID/FEI	Business Operations
Establishment
NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.		530766098	manufacture(76176-122)