SPOT CARE PINK ONE by Leejiham 80395-202

SPOT CARE PINK ONE by

Drug Labeling and Warnings

SPOT CARE PINK ONE by is a Otc medication manufactured, distributed, or labeled by Leejiham. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPOT CARE PINK ONE- alcohol, salicylic acid, glycerin liquid 
Leejiham

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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80395-202

Active ingredient

Alcohol 2%

Glycerin 0.19%

Salicylic Acid 0.3%

Purpose

Skin Protectant

Acne

Uses

Mild gel type cleanser helps skin refresh by removing excessive sebum on surface and the pores.

Directions

Apply a suitable amount of product and gently wash off.

Inactive ingredients

Water, Cocamidopropyl Betaine, Sodium Laureth Sulfate, Ammonium Lauryl Sulfate, Sodium Chloride, Alcohol, Phenoxyethanol, Salicylic Acid, Chlorphenesin, PEG-60 Almond Glycerides, Glycerin, Carbomer, Nordihydroguaiaretic Acid, Oleanolic Acid, Sodium Hyaluronate, Panthenol, Hydrogenated Lecithin, Niacinamide, Raffinose, Ceramide NP, Phytosphingosine, Cholesterol, Hydrogenated Starch Hydrolysate, Glycosyl Trehalose, Disodium Cocoamphodiacetate, Pantolactone, Candida Bombicola/Glucose/Methyl Rapeseedate Ferment, Silkworm Extract, Fragrance

Warnings

For external use only

Stop use and ask a physician

if skin irritation and redness occurs more than 72 hours.

Do not use

on damaged or broken skin

Keep out of reach of children

If swallowed, get medical help right away.

Other information

Protect this product from direct sun and excessive heat

Package Label

SPOT CARE PINK ONE 
alcohol, salicylic acid, glycerin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80395-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.3 g  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.19 g  in 100 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	2 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
BEMISIOSE (UNII: 76B4LOB2YC)
RAFFINOSE (UNII: N5O3QU595M)
CERAMIDE NP (UNII: 4370DF050B)
CHOLESTEROL (UNII: 97C5T2UQ7J)
PANTHENOL (UNII: WV9CM0O67Z)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
PANTOLACTONE, (R)- (UNII: J288D7O0JS)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BOMBYX MORI LARVA (UNII: 1WYM0QWX33)
CHLORPHENESIN (UNII: I670DAL4SZ)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
NIACINAMIDE (UNII: 25X51I8RD4)
PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)
NORDIHYDROGUAIARETIC ACID, (+/-)- (UNII: 7PZ73W4ZNR)
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80395-202-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	09/01/2020	12/31/2021

Labeler - Leejiham (695004132)

Registrant - Leejiham (695004132)

Establishment
Name	Address	ID/FEI	Business Operations
Leejiham		695004132	manufacture(80395-202)

Revised: 6/2022

Document Id: e173f92d-7b90-995b-e053-2995a90aa631

34390-5

Set id: ae3e559d-51af-08cd-e053-2a95a90a4790

Version: 3

Effective Time: 20220614