SPL v1
SPL
SPL Set ID aeea9b0c-8dda-a247-e053-2995a90ae0f7
Route
TOPICAL
Published
Effective Date 2020-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (50.967 g)
Inactive Ingredients
Aloe Vera Leaf Green Tea Leaf Water Citric Acid Monohydrate Matricaria Recutita

Identifiers & Packaging

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

Description

alcohol


Medication Information

Warnings and Precautions

For external use only. Flammable. Keep away from heat or flame.

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

pull ouy wipes and sanitize hands when necessary

Dosage and Administration

for external use only

Description

alcohol

Section 50565-1

keep out of reach of the children

Section 51727-6

Water

Glycerin

Aloe Barbadensis Leaf Extract

Camellia Sinensis Leaf Extract

Chamomilla Recutita (Matricaria) Extract

Section 51945-4

Section 55105-1

hand sanitizing tissue to help reduce bacteria on the skin

Section 55106-9

alcohol


Structured Label Content

Indications and Usage (34067-9)

pull ouy wipes and sanitize hands when necessary

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

For external use only. Flammable. Keep away from heat or flame.

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

Water

Glycerin

Aloe Barbadensis Leaf Extract

Camellia Sinensis Leaf Extract

Chamomilla Recutita (Matricaria) Extract

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

hand sanitizing tissue to help reduce bacteria on the skin

Section 55106-9 (55106-9)

alcohol


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)