FDA.reportPublic FDA data

COTTON HAIR REMOVAL

Manufacturer
NATURE REPUBLIC CO., LTD. | Kolmar Korea Co.,LTD. Gwanjeong Factory
Effective date
2019-12-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:47:38

Label at a glance#

ProductCOTTON HAIR REMOVAL
Active ingredientDIMETHICONE
Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS: DIMETHICONE (1.00%)

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: WATER,UREA,CETEARYL ALCOHOL,MINERAL OIL,THIOGLYCOLIC ACID,ISOPROPYL PALMITATE,CALCIUM HYDROXIDE,CETEARETH-20,POTASSIUM HYDROXIDE,PPG-15 STEARYL ETHER,PROPYLENE GLYCOL,BIOSACCHARIDE GUM-1,LITHIUM MAGNESIUM SODIUM SILICATE,FRAGRANCE,MICROCRYSTALLINE WAX,BHT,SODIUM METABISULFITE,SODIUM MAGNESIUM SILICATE,ANTHEMIS NOBILIS FLOWER EXTRACT,CAMELLIA SINENSIS LEAF EXTRACT,GOSSYPIUM HERBACEUM (COTTON) SEED OIL,SALVIA OFFICINALIS (SAGE) LEAF EXTRACT,GLYCERYL STEARATE,PEG-100 STEARATE,DISODIUM EDTA

PURPOSE

OTC - PURPOSE SECTION

PURPOSE: [SKIN PROTECTANT] Wash-off type mild hair removal cream removes hair fast and easily without skin irritation

CAUTIONS

WARNINGS SECTION

CAUTIONS: 1. For external use only 2. Avoid contact with eyes and mouth 3. Discontinue us if signs of irritation or rashes appear 4. Keep out of reach of children 5. Replace the cap after use

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

HOW TO USE: After cleansing desired area, apply a thick and even layer to the area. Do not rub in. Leave the cream on for 5-10 minutes. After 5-10 minutes, test a small area by wiping cream away with fingers. If the hair removes easily, wipe cream away with wet-towel or wet-tissue, then rinse thoroughly with lukewarm water. If you want to remove harsh and short hairs completely, use the product more than once (reapply the product at least after 24 hour).

EFFICIENCY & EFFECT: Hair removal (body hair)

TIP: After applying the removal cream on desired area, wait 2-3 minutes and wipe a small part off. If the hair is removed easily, rinse off with water. *Don’t keep it on for more than 10 minutes.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

HOW TO USE: After cleansing desired area, apply a thick and even layer to the area. Do not rub in. Leave the cream on for 5-10 minutes. After 5-10 minutes, test a small area by wiping cream away with fingers. If the hair removes easily, wipe cream away with wet-towel or wet-tissue, then rinse thoroughly with lukewarm water. If you want to remove harsh and short hairs completely, use the product more than once (reapply the product at least after 24 hour).

EFFICIENCY & EFFECT: Hair removal (body hair)

TIP: After applying the removal cream on desired area, wait 2-3 minutes and wipe a small part off. If the hair is removed easily, rinse off with water. *Don’t keep it on for more than 10 minutes.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1O1
DIMETHICONEACTIVE MOIETY92RU3N3Y1O1
UREAINACTIVE INGREDIENT8W8T17847W1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51346-32051346-320-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
WATER059QF0KO0RIACT
UREA8W8T17847WIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 7 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
UREAUREA8W8T17847WSYSTEM / TOPICAL840 mgExact identifier — unii candidate
7 equally ranked IID candidates
UREAUREA8W8T17847WTABLET, EFFERVESCENT / ORAL60 mgExact identifier — unii candidate
7 equally ranked IID candidates
UREAUREA8W8T17847WDOUCHE / VAGINAL8 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
UREAUREA8W8T17847WCREAM / VAGINAL0.64 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
UREAUREA8W8T17847WTABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
7 equally ranked IID candidates
UREAUREA8W8T17847WINSERT / VAGINAL50 mgExact identifier — unii candidate
7 equally ranked IID candidates
UREAUREA8W8T17847WTABLET, COATED / ORAL0.02 mgExact identifier — unii candidate
7 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1a1da3f8-f4fc-4547-ba4a-53b2e89d7932a5bf2215-bb8c-4a26-a984-99a348e431e92021-06-23WarningsExact identifier
spl set id: a5bf2215-bb8c-4a26-a984-99a348e431e9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.