Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID af51cc6b-eda6-dd90-e053-2995a90a508d
Route
TOPICAL
Published
Effective Date 2020-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Limonene, (+)- Trolamine Rosemary Oil Matricaria Recutita Glycerin Orange Oil Carbomer 940 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-15

Description

alcohol


Medication Information

Warnings and Precautions

1. Do not use on the following body parts. A wide range of body parts and damaged skin around the eyes and

ears, in the oral cavity (may have irritating effects)

2. If the following symptoms appear, stop using them immediately and consult a doctor or pharmacist.

1) Hypersensitivity symptoms such as rash, erythema, itching, and edema

2) Skin irritation symptoms

3. Other precautions

1) For external use only (do not underwear).

2) Be careful not to get into your eyes, and if so, rinse well with clean water and consult a doctor or pharmacist.

3) Be careful not to inhale the vapor when using it extensively or for a long period of time (irritation to the

mucous membranes, headaches, etc. may occur if ethanol vapor is consumed in large quantities or repeatedly).

4) If repeated use on the same site, be careful as the skin may become rough due to degreasing.

5) Do not use sealed bandages, cast bandages, packs, etc., as irritation may occur.

6) Do not use this medicine for anal or vaginal compresses as it may cause irritation or chemical burns.

7) Do not use for any other purpose.

4. Precautions for storage

1) Avoid shading and keep in shading.

2) Keep it out of reach of children, and if a child swallows it, go to the hospital right away.

3) After use, close the product completely with a lid to prevent the product from drying out or entering foreign

Objects.

Indications and Usage

Apply an appropriate amount on your hands and rub well to dry.

Dosage and Administration

for external use only

Description

alcohol

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

Water

Glycerin

Carbomer

Triethanolamine

Rosmarinus Officinalis (Rosemary) Leaf Extract

Chamomilla Recutita (Matricaria) Flower Extract

Rose Centifolia Flower Water

Citrus Aurantium Dulcis (Orange) Oil

Limonene

Section 51945-4

Section 55105-1

Sterilization of hands and skin

Section 55106-9

alcohol


Structured Label Content

Indications and Usage (34067-9)

Apply an appropriate amount on your hands and rub well to dry.

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

1. Do not use on the following body parts. A wide range of body parts and damaged skin around the eyes and

ears, in the oral cavity (may have irritating effects)

2. If the following symptoms appear, stop using them immediately and consult a doctor or pharmacist.

1) Hypersensitivity symptoms such as rash, erythema, itching, and edema

2) Skin irritation symptoms

3. Other precautions

1) For external use only (do not underwear).

2) Be careful not to get into your eyes, and if so, rinse well with clean water and consult a doctor or pharmacist.

3) Be careful not to inhale the vapor when using it extensively or for a long period of time (irritation to the

mucous membranes, headaches, etc. may occur if ethanol vapor is consumed in large quantities or repeatedly).

4) If repeated use on the same site, be careful as the skin may become rough due to degreasing.

5) Do not use sealed bandages, cast bandages, packs, etc., as irritation may occur.

6) Do not use this medicine for anal or vaginal compresses as it may cause irritation or chemical burns.

7) Do not use for any other purpose.

4. Precautions for storage

1) Avoid shading and keep in shading.

2) Keep it out of reach of children, and if a child swallows it, go to the hospital right away.

3) After use, close the product completely with a lid to prevent the product from drying out or entering foreign

Objects.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

Water

Glycerin

Carbomer

Triethanolamine

Rosmarinus Officinalis (Rosemary) Leaf Extract

Chamomilla Recutita (Matricaria) Flower Extract

Rose Centifolia Flower Water

Citrus Aurantium Dulcis (Orange) Oil

Limonene

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sterilization of hands and skin

Section 55106-9 (55106-9)

alcohol


Advanced Ingredient Data


Raw Label Data

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