a34bfe09-5f66-cf9b-e053-2995a90a0d62

SPL v1
SPL
SPL Set ID a34bfe09-5f66-cf9b-e053-2995a90a0d62
Route
topical
Published
Effective Date 2020-04-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (0.025 g)
Inactive Ingredients
lemon trolamine bergamot oil carbomer 934 alpha-tocopherol glycerin aloe vera leaf water jojoba oil

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-04-15

Purpose

Antiseptic

Description

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic


Medication Information

Warnings

KEEP AWAY FROM FIRE OR FLAME.FOR EXTERNAL USE ONLY:HANDS

Purpose

Antiseptic

Directions

PLACE ENOUGH PRODUCT IN YOU PALM TO THOROUGHLY SPREAD ON BOTH HANDS AND RUB INTO THE SKIN UNTIL DRY.CHILDREN UNDER 6 YEARS OF AGE SHUOULD BE SUPERVISED WHEN USING THIS PRODUCT.

Other Information

STORE BELOW 41C.MAY DISCOLOR CERTAIN FABRICS OR SURFACES.

Inactive Ingredients

TROLAMINE,BERGAMOT OIL,CARBOMER 934,JOJOBA OIL,GLYCERIN,

ALOE VERA LEAF,WATER,LEMON,VITAMIN E

Description

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Use

TO DECREASE BACTERIA ON THE SKIN ,RECOMMENDED FOR REPEATED USE.

Section 50565-1

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

Section 50566-9

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

Section 50567-7

DO NOT USE IN OR NEAR IN OR HEAR THE EYES.IN CASE OF CONTACT,RINSE EYES THOROUGHLY WITH WATER.STOP USE AND ASK DOCTOR IF IRRITATION OR RASH APPEARS AND LASTS. KEEP OUT OF REACH FOR CHILDREN.

Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Package Label Principal Display Panel


Structured Label Content

Warnings

KEEP AWAY FROM FIRE OR FLAME.FOR EXTERNAL USE ONLY:HANDS

Purpose

Antiseptic

Directions

PLACE ENOUGH PRODUCT IN YOU PALM TO THOROUGHLY SPREAD ON BOTH HANDS AND RUB INTO THE SKIN UNTIL DRY.CHILDREN UNDER 6 YEARS OF AGE SHUOULD BE SUPERVISED WHEN USING THIS PRODUCT.

Other Information (Other information)

STORE BELOW 41C.MAY DISCOLOR CERTAIN FABRICS OR SURFACES.

Inactive Ingredients (Inactive ingredients)

TROLAMINE,BERGAMOT OIL,CARBOMER 934,JOJOBA OIL,GLYCERIN,

ALOE VERA LEAF,WATER,LEMON,VITAMIN E

Use

TO DECREASE BACTERIA ON THE SKIN ,RECOMMENDED FOR REPEATED USE.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

DO NOT USE IN OR NEAR IN OR HEAR THE EYES.IN CASE OF CONTACT,RINSE EYES THOROUGHLY WITH WATER.STOP USE AND ASK DOCTOR IF IRRITATION OR RASH APPEARS AND LASTS. KEEP OUT OF REACH FOR CHILDREN.

Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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