SPL v1
SPL
SPL Set ID 1e0968d7-48c3-5402-e063-6394a90a5903
Route
CUTANEOUS
Published
Effective Date 2024-07-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.25 mg)
Inactive Ingredients
Niacinamide Mineral Oil Dmdm Hydantoin Ethylhexyl Palmitate Myristyl Myristate Dimethicone Propylparaben Glyceryl Monostearate Palmitic Acid Water Lauric Acid Sodium Hydroxide Glycerin Peg-100 Stearate Cetostearyl Alcohol Carboxypolymethylene

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-25

Description

Uses: For exfoliation and whitening


Medication Information

Warnings and Precautions



Warning.

1.Before use, perform a skin test on your arm and discontinue use if you have allergy symptoms or skin abnormalities.

2、For external use only, avoid contact with eyes when used

3、Keep out of reach of children

Indications and Usage

Apply for 3 consecutive night before bedtime. Make it thioker to achoieve large pooling. Repeat 3X application with 15 mins interval.

Dosage and Administration

Apply for 3 consecutive night before bedtime. Make it thioker to achoieve large pooling. Repeat 3X application with 15 mins interval.

Description

Uses: For exfoliation and whitening

Section 50565-1

KEEP OUT OF REACH OF CHILDREN SECTION

Section 51727-6

AQUA、MINERAL OIL、GLYCERIN、ETHYLHEXYL PALMITATE、GLYCERYL STEARATE、LAURIC ACID、MYRISTYL MYRISTATE、PALMITIC ACID、PEG-100 STEARATE、CETEARYL ALCOHOL、DIMETHICONE、NIACINAMIDE、DMDM HYDANTOIN、CARBOMER、PROPYLPARABEN、SODIUM HYDROXIDE

Section 51945-4



Active Ingredients

SALICYLIC ACID 0.5%

Uses:

For exfoliation and whitening

The storage method:

Store sealed in a cool place and out of sunlight

Warning.

1.Before use, perform a skin test on your arm and discontinue use if you have allergy symptoms or skin abnormalities.

2、For external use only, avoid contact with eyes when used

3、Keep out of reach of children

Inactive ingredients:

AQUA、MINERAL OIL、GLYCERIN、ETHYLHEXYL PALMITATE、GLYCERYL STEARATE、LAURIC ACID、MYRISTYL MYRISTATE、PALMITIC ACID、PEG-100 STEARATE、CETEARYL ALCOHOL、DIMETHICONE、NIACINAMIDE、DMDM HYDANTOIN、CARBOMER、PROPYLPARABEN、SODIUM HYDROXIDE

Section 55105-1

Uses:

For exfoliation and whitening

Section 55106-9



Active Ingredients

SALICYLIC ACID 0.5%




Structured Label Content

Indications and Usage (34067-9)

Apply for 3 consecutive night before bedtime. Make it thioker to achoieve large pooling. Repeat 3X application with 15 mins interval.

Dosage and Administration (34068-7)

Apply for 3 consecutive night before bedtime. Make it thioker to achoieve large pooling. Repeat 3X application with 15 mins interval.

Warnings and Precautions (34071-1)



Warning.

1.Before use, perform a skin test on your arm and discontinue use if you have allergy symptoms or skin abnormalities.

2、For external use only, avoid contact with eyes when used

3、Keep out of reach of children

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN SECTION

Section 51727-6 (51727-6)

AQUA、MINERAL OIL、GLYCERIN、ETHYLHEXYL PALMITATE、GLYCERYL STEARATE、LAURIC ACID、MYRISTYL MYRISTATE、PALMITIC ACID、PEG-100 STEARATE、CETEARYL ALCOHOL、DIMETHICONE、NIACINAMIDE、DMDM HYDANTOIN、CARBOMER、PROPYLPARABEN、SODIUM HYDROXIDE

Section 51945-4 (51945-4)



Active Ingredients

SALICYLIC ACID 0.5%

Uses:

For exfoliation and whitening

The storage method:

Store sealed in a cool place and out of sunlight

Warning.

1.Before use, perform a skin test on your arm and discontinue use if you have allergy symptoms or skin abnormalities.

2、For external use only, avoid contact with eyes when used

3、Keep out of reach of children

Inactive ingredients:

AQUA、MINERAL OIL、GLYCERIN、ETHYLHEXYL PALMITATE、GLYCERYL STEARATE、LAURIC ACID、MYRISTYL MYRISTATE、PALMITIC ACID、PEG-100 STEARATE、CETEARYL ALCOHOL、DIMETHICONE、NIACINAMIDE、DMDM HYDANTOIN、CARBOMER、PROPYLPARABEN、SODIUM HYDROXIDE

Section 55105-1 (55105-1)

Uses:

For exfoliation and whitening

Section 55106-9 (55106-9)



Active Ingredients

SALICYLIC ACID 0.5%




Advanced Ingredient Data


Raw Label Data

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