HAND SANITIZER PUMP SWEET MELON- alcohol gel

미국 - 영어 - NLM (National Library of Medicine)

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제품 특성 요약 제품 특성 요약 (SPC)

04-05-2021

유효 성분:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
제공처:
BASE4 Ventures, Inc
관리 경로:
TOPICAL
처방전 유형:
OTC DRUG
치료 징후:
- hand sanitizer to help decrease bacteria on the skin. - recommended for repeated use.
승인 상태:
OTC monograph not final
승인 번호:
62651-046-01

전체 문서 읽기

HAND SANITIZER PUMP SWEET MELON- alcohol gel

BASE4 Ventures, Inc

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.

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Hand Sanitizer Pump Sweet Melon

Drug Facts

Active Ingredient

Alcohol Denat. 66% (V/V)

Purpose

Antiseptic

Uses

hand sanitizer to help decrease bacteria on the skin.

recommended for repeated use.

Warnings

For external use only.

Flammable.

Keep away from heat or flame.

Does not contain grain alcohol; do not drink. If taken internally will

produce severe gastric disturbances.

When using this product,

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

if redness or irritation develop and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center immediately.

Directions

Rub dime sized amount between hands until dry.

Supervise children in the use of this product. In the case of eye contact rinse eyes

thoroughly with water

Other information

Do not store above 105°F.

May discolor some fabrics.

Inactive ingredients

Acrylates/C10-30 alkyl acrylates crosspolymer, Aminomethyl propanol, D&C Red No.33,

Disodium EDTA, FD&C Blue No.1, FD&C Red No.4, FD&C Yellow No.5, Fragrance, Water

Package Labeling:

HAND SANITIZER PUMP SWEET MELON

alcohol gel

Product Information

Product Type

HUMAN OTC DRUG

Item Code (Source)

NDC:62651-046

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Strength

ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)

ALCOHOL

0.66 mL in 1 mL

Inactive Ingredients

BASE4 Ventures, Inc

Ingredient Name

Strength

AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

D&C RED NO. 33 (UNII: 9DBA0SBB0L)

EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

FD&C RED NO. 4 (UNII: X3W0AM1JLX)

FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

WATER (UNII: 059QF0KO0R)

CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)

Packaging

# Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:62651-

046-01

236.5 mL in 1 BOTTLE; Type 0: Not a Combination

Product

12/04/2020

12/04/2021

Marketing Information

Marketing

Category

Application Number or Monograph

Citation

Marketing Start

Date

Marketing End

Date

OTC monograph not

final

part333E

12/04/2020

12/04/2021

Labeler -

BASE4 Ventures, Inc (137316126)

Revised: 5/2021

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