SIMPLEPLEASURES SCENTED ANTI BACTERIAL HAND SANITIZER- alcohol liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Tri-Coastal Design Company Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic ■ For handwashing to decrease bacteria on the skin ■ Recommended for repeated use ■ Condition worsens ■ Redness or irritation develops ■ If condition persists for more than 3 days
Authorization status:
OTC monograph not final
Authorization number:
49852-156-01

SIMPLEPLEASURES SCENTED ANTI BACTERIAL HAND SANITIZER- alcohol liquid

Tri-Coastal Design Company 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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simplepleasures winter snow Hand Sanitizer

Active Ingredient

Alcohol 62%

Purpose

Antiseptic

Uses

■ For handwashing to decrease bacteria on the skin

■ Recommended for repeated use

Warnings

■ For external use only ■ Flammable, keep away from fire and flame ■ Does not contain grain alcohol;

do not drink, if taken internally will produce serious gastric disturbances

When using this product

■ Avoid the eyes and mucous membranes ■ In the case of eyes or mucous membrane contact; rinse area

thoroughly with water

Stop use and ask a doctor if

■ Condition worsens ■ Redness or irritation develops ■ If condition persists for more than 3 days

Keep out of reach of children

■ If swallowed, get medical help or Poison Control Center right away.

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

■ Store below 105ºF ■ May discolor some fabrics

Inactive ingredients

Water, PEG-40 Hydrogenated Castor Oil, Fragrance, Acrylates/C10-30 Alkyl Acetate Crosspolymer,

Sodium Hydroxide, FD&C Blue No. 1 (CI42090), D&C Red No. 33 (CI17200)

Questions?

■ 1-800-278-9218

Package Label

SIMPLEPLEASURES SCENTED ANTI BACTERIAL HAND SANITIZER

alcohol liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:49 8 52-156

Route of Administration

TOPICAL

Tri-Coastal Design Company Inc.

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

6 2 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)

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

WATER (UNII: 0 59 QF0 KO0 R)

CARBO MER INTERPO LYMER TYPE A ( 550 0 0 CPS) (UNII: 59 TL3WG5CO)

PO LYO XYL 4 0 HYDRO GENATED CASTO R O IL (UNII: 7YC6 8 6 GQ8 F)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:49 8 52-156 -

30 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /12/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

0 8 /12/20 19

Labeler -

T ri-Coastal Design Company Inc. (609734900)

Revised: 2/2020

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