MELAO CALLUS REMOVER- pumice,urea gel

MELAO Callus remover by

Drug Labeling and Warnings

MELAO Callus remover by is a Otc medication manufactured, distributed, or labeled by Guangzhou Yilong Cosmetics Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Pumice Extract 5%

Urea 2%

Purpose

Exfoliate.

Uses

Put Gloves on.
1. Soak feet in warm water until prune-like.

2. Pre scrub with pumice stone or foot rasp.(Optional but recommended)

3. Towel dry one foot, apply callus remover to hard and dry callused areas(avoid soft skin), and let sit for 5-10 minutes.
4. You can scrub with pumice or rasp while callus remover is on.(Optional but recommended)

5. Rinse foot and use pumice stone or rasp to remove extra residue of callus remover and dead skin.

6. Repeat above process for other foot.Note: Some peoples calluses maybe worse than others, so repeat callus remover process as necessary.

WARNINGS

For external use only.

Stop use and ask a doctor if

rash occurs.

Do not use

on damaged or broken skin.

When using this product

keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

1. Soak feet in warm water untilprune-like.

2. Pre scrub with pumice stone orfoot rasp.

3. Towel dry one foot, apply callusremover to hard
and dry callusedareas, and let sit for 5-10 minutes.

INACTIVE INGREDIENT

METHYL DIISOPROPYL PROPIONAMIDE
ETHYL MENTHANE CARBOXAMIDE
WATER
GLYCERIN
MENTHYL LACTATE, (-)
LAURYL LAURATE
POTASSIUM HYDROXIDE
ZEA MAYS WHOLE
CARBOMER 940

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MELAO CALLUS REMOVER 
pumice,urea gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83566-276
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PUMICE (UNII: NT5NN5KL16) (PUMICE - UNII:NT5NN5KL16)	PUMICE	5 mg  in 100 mL
(4-(TRIFLUOROMETHOXY)PHENYL)UREA (UNII: SQP4E8O29W) ((4-(TRIFLUOROMETHOXY)PHENYL)UREA - UNII:SQP4E8O29W)	(4-(TRIFLUOROMETHOXY)PHENYL)UREA	2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
LAURYL LAURATE (UNII: GPW77G0937)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
ZEA MAYS WHOLE (UNII: 1G5HNE09V8)
CARBOMER 940 (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83566-276-01	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/20/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M030	12/20/2023

Labeler - Guangzhou Yilong Cosmetics Co.,Ltd. (712647107)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Yilong Cosmetics Co.,Ltd.		712647107	manufacture(83566-276)