OTC Medication Information: Clean And Hand

CLEAN AND HAND- alcohol gel
Enprani Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredients: ALCOHOL 62% w/w

INACTIVE INGREDIENT

Inactive ingredients:
Water, Butylene Glycol, Carbomer

PURPOSE

Purpose: ANTISEPTIC

WARNINGS

Warnings:

For external use only. Flammable. Keep away from heat or flame
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Do not use
• in children less than 2 months of age
• on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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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

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

Uses

Uses:

Hand sanitizer to help reduce bacteria that potentially can cause disease.

Directions

Directions:

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Other information
• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

PACKAGE LABEL — CLEAN & HAND GEL 55mL

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PACKAGE LABEL — CLEAN & HAND GEL 250mL

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PACKAGE LABEL — CLEAN & HAND GEL 500mL

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CLEAN AND HAND
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69551-051
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 62 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
Water
Butylene Glycol
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69551-051-01 55 mL in 1 BOTTLE None
2 NDC:69551-051-02 250 mL in 1 BOTTLE, PUMP None
3 NDC:69551-051-03 500 mL in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 04/01/2020
Labeler — Enprani Co., Ltd. (631100112)
Registrant — Enprani Co., Ltd. (631100112)
Establishment
Name Address ID/FEI Operations
Opseve KOREA Co.,Ltd. 690048629 manufacture (69551-051)

Revised: 04/2020 Enprani Co., Ltd.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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