Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID e798ab66-d0a7-4b60-961e-e833e2e33a18
Route
TOPICAL
Published
Effective Date 2012-02-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2.4 mL)
Inactive Ingredients
Levomenthol Fallopia Multiflora Root Oenothera Biennis Aloe Vera Leaf Peppermint Oil Alcohol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-09-01

Description

Active Ingredient: Salicylic acid 2%


Medication Information

Warnings and Precautions

WARNINGS:

If side-effects, such as redness, itching or swelling occur, discontinue use. If airritation continues after discontinuing use, consult a dermatologist.

1. If a red area develops using this product or there is swelling or itchyness, consult a dermatologist.

2. Exposure to direct sunlight may cause side-effects as above.

3. Do not apply product to an area of skin that is affected by eczema or dermatitis.

4. Wash eyes immediately and thoroughly if product enters eyes.

Indications and Usage

Indication and usage:

Damoae Therapy hair tonic on the scalp 3-4 times by shaking finger tips touching the hair, the locals sprinkle with fingerprints on the scalp 3-5 minutes to fully absorb the massage.

- 1 day , 2 to 3 times as above is used.

Dosage and Administration

Dosage and administration:

Do pumping enough amount of hair tonic (2-3 times). Rub it with finger tip slowly as if you gave a massage for 3-5 minutes.

Description

Active Ingredient: Salicylic acid 2%

Section 50565-1

Keep out of reach of children:

Replace the caps after use.

Keep away from babies and children.

Section 51727-6

Inactive Ingredients:

L-menthol, Dexpantenol, Citrus Unshiu Peel extract, polygonum multiflorum root extract, Oenothera Biennis Oil, Aloe Barbadensis Leaf Juice, Mentha Piperita (Peppermint) Oil, Polyoxyethylene Hydrogenated Castor Oil, Sodium Citrate Hydrate, Ethanol, Purified Water

Section 51945-4

Section 55105-1

Purpose: Dandruff

Section 55106-9

Active Ingredient: Salicylic acid 2%


Structured Label Content

Indications and Usage (34067-9)

Indication and usage:

Damoae Therapy hair tonic on the scalp 3-4 times by shaking finger tips touching the hair, the locals sprinkle with fingerprints on the scalp 3-5 minutes to fully absorb the massage.

- 1 day , 2 to 3 times as above is used.

Dosage and Administration (34068-7)

Dosage and administration:

Do pumping enough amount of hair tonic (2-3 times). Rub it with finger tip slowly as if you gave a massage for 3-5 minutes.

Warnings and Precautions (34071-1)

WARNINGS:

If side-effects, such as redness, itching or swelling occur, discontinue use. If airritation continues after discontinuing use, consult a dermatologist.

1. If a red area develops using this product or there is swelling or itchyness, consult a dermatologist.

2. Exposure to direct sunlight may cause side-effects as above.

3. Do not apply product to an area of skin that is affected by eczema or dermatitis.

4. Wash eyes immediately and thoroughly if product enters eyes.

Section 50565-1 (50565-1)

Keep out of reach of children:

Replace the caps after use.

Keep away from babies and children.

Section 51727-6 (51727-6)

Inactive Ingredients:

L-menthol, Dexpantenol, Citrus Unshiu Peel extract, polygonum multiflorum root extract, Oenothera Biennis Oil, Aloe Barbadensis Leaf Juice, Mentha Piperita (Peppermint) Oil, Polyoxyethylene Hydrogenated Castor Oil, Sodium Citrate Hydrate, Ethanol, Purified Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Dandruff

Section 55106-9 (55106-9)

Active Ingredient: Salicylic acid 2%


Advanced Ingredient Data


Raw Label Data

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