SPOT CARE BLUE ONE by Leejiham 80395-203

SPOT CARE BLUE ONE by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPOT CARE BLUE ONE- alcohol, lactic acid, salicylic acid, benzyl alcohol, 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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80395-203

Active ingredient

Alcohol 80%

Lactic Acid 0.9%

Salicylic Acid 0.45%

Glycerin 0.02%

Benzyl Alcohol 0.1%

Purpose

Skin Protectant

Acne

Uses

Water type ampule for acne skin caused by excessive sebum and dead skin cells clogging pores.

Directions

After cleansing, soak cotton butt or cotton pad and apply on acnes.

Inactive ingredients

Alcohol, Water, Lactic Acid, Candida Bombicola/Glucose/Methyl Rapeseedate Ferment, Salicylic Acid, Phytosphingosine, Glycerin, Panthenol, Hydrogenated Lecithin, Niacinamide, Raffinose, Ceramide NP, Cholesterol, Hydrogenated Starch Hydrolysate, Glycosyl Trehalose, Ethylhexylglycerin, Silkworm Extract, Scutellaria Baicalensis Root Extract, Illicium Verum (Anise) Fruit Extract, 1,2-Hexanediol, PEG-60 Almond Glycerides, Caprylyl Glycol, Carbomer, Butylene Glycol, Nordihydroguaiaretic Acid, Oleanolic Acid, Benzyl Alcohol

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 BLUE ONE 
alcohol, lactic acid, salicylic acid, benzyl alcohol, glycerin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80395-203
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT)	LACTIC ACID	0.9 g  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.02 g  in 100 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL
BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH)	BENZYL ALCOHOL	0.1 g  in 100 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.45 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PANTHENOL (UNII: WV9CM0O67Z)
NIACINAMIDE (UNII: 25X51I8RD4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
NORDIHYDROGUAIARETIC ACID, (+/-)- (UNII: 7PZ73W4ZNR)
BOMBYX MORI LARVA (UNII: 1WYM0QWX33)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
CERAMIDE NP (UNII: 4370DF050B)
BEMISIOSE (UNII: 76B4LOB2YC)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
RAFFINOSE (UNII: N5O3QU595M)
PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)
STAR ANISE FRUIT (UNII: CK15HA8438)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BIOTIN (UNII: 6SO6U10H04)
CHOLESTEROL (UNII: 97C5T2UQ7J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80395-203-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/02/2020	12/31/2021
2	NDC: 80395-203-02	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/02/2020	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	09/02/2020	12/31/2021

Labeler - Leejiham (695004132)

Registrant - Leejiham (695004132)

Establishment
Name	Address	ID/FEI	Business Operations
Leejiham		695004132	manufacture(80395-203)

Revised: 6/2022

Document Id: e173e20e-ef17-5721-e053-2995a90a4894

34390-5

Set id: ae4a61d9-edd7-21d5-e053-2995a90a096b

Version: 4

Effective Time: 20220614