L-Topical WHITE PETROLATUM USP (30%)

L-Topical WHITE PETROLATUM 30% by

Drug Labeling and Warnings

L-Topical WHITE PETROLATUM 30% by is a Otc medication manufactured, distributed, or labeled by GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

L-TOPICAL WHITE PETROLATUM 30%- white petrolatum gel 
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED

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.

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L-Topical WHITE PETROLATUM USP (30%)

DRUG FACTS

Active ingredient

WHITE PETROLATUM USP (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 or 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.

Questions?

Call toll-free 1-800-572-6632, Weekdays 7:00 AM - 5.30 PM EST.

Inactive ingredients

Water (Aqua), Caprylic/Capric Triglyceride, Stearic Acid, Glycerin, Sodium Hydroxypropyl Starch Phosphate, Glycol Stearate, PEG-100 Stearate, Glyceryl Stearate, Cetyl Alcohol, Phenoxyethanol, Methylparaben, Isopropyl Myristate, Propylparaben, Stearamide AMP, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Potassium Hydroxide, Cedrol, Tocopheryl Acetate, Titanium Dioxide (CI 77891).

√ Heals severely dry skin

√ Skin protectant

Manufactured by :

Global Pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

L-TOPICAL WHITE PETROLATUM 30% 
white petrolatum gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73921-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	300 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXYPROPYLSULFONATE LAURYLGLUCOSIDE-7 CROSSPOLYMER (UNII: K9R4VJQ1IB)
GLYCOL STEARATE (UNII: 0324G66D0E)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETYL ALCOHOL (UNII: 936JST6JCN)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARAMIDE AMP (UNII: U3K8640346)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
CEDROL (UNII: 63ZM9703BO)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73921-030-04	118 mL in 1 CONTAINER; Type 0: Not a Combination Product	04/01/2021	02/08/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/01/2021	02/08/2023

Labeler - GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)

Establishment
Name	Address	ID/FEI	Business Operations
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED		860186917	manufacture(73921-030)

Revised: 2/2023

Document Id: f42bf796-3027-7224-e053-2995a90a7f5a

34390-5

Set id: 646e49fc-562f-4aa1-a2d7-e62856c84f9d

Version: 2

Effective Time: 20230208