OTC Medication Information: L-Topical WHITE PETROLATUM 30%

L-TOPICAL WHITE PETROLATUM 30%- 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.

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

LTopical30
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PETROLATUM (PETROLATUM) PETROLATUM 300 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
MEDIUM-CHAIN TRIGLYCERIDES
STEARIC ACID
GLYCERIN
SODIUM HYDROXYPROPYLSULFONATE LAURYLGLUCOSIDE-7 CROSSPOLYMER
GLYCOL STEARATE
PEG-100 STEARATE
GLYCERYL MONOSTEARATE
CETYL ALCOHOL
PHENOXYETHANOL
METHYLPARABEN
ISOPROPYL MYRISTATE
PROPYLPARABEN
STEARAMIDE AMP
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
EDETATE DISODIUM ANHYDROUS
POTASSIUM HYDROXIDE
CEDROL
.ALPHA.-TOCOPHEROL ACETATE
TITANIUM DIOXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73921-030-04 118 mL in 1 CONTAINER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 04/01/2021
Labeler — GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)
Establishment
Name Address ID/FEI Operations
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED 860186917 manufacture (73921-030)

Revised: 03/2021 GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED

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.

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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