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NDC 81755-0002-92 Shimmy Rose Hibiscus Hand Sanitizer 70 mg/100mL Details

Shimmy Rose Hibiscus Hand Sanitizer 70 mg/100mL

Shimmy Rose Hibiscus Hand Sanitizer is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Shimmy Products LLC. The primary component is ALCOHOL.

Product Information

NDC	81755-0002
Product ID	81755-002_c50b6ea2-54e1-70f3-e053-2a95a90a4ac6
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Shimmy Rose Hibiscus Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	mg/100mL
Substance Name	ALCOHOL
Labeler Name	Shimmy Products LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 81755-0002-92 (81755000292)

Pricing Information	N/A
NDC Package Code	81755-002-92
Billing NDC	81755000292
Package	236 mL in 1 CAN (81755-002-92)
Marketing Start Date	2021-06-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c50b5044-31fd-672a-e053-2995a90a49fc Details

Active Ingredients

Ethyl Alcohol 70% v/v

Purpose

Antimicrobial

Uses

hand sanitizer to help reduce bacteria on the skin that could cause disease.
for use when soap and water are not available

Warnings

For external use only.

Flammable. Keep away from heat or flame.

Do not use

on 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 eyes thoroughly with water.

Stop use and ask a doctor

if irritation or rash appears or lasts. 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.

Directions

Put enough product in your palm to cover your hands and rub hands together briskly until dry
Children under 6 years of age should be supervised when using this product.

Other information

Avoid freezing and excessive heat above 40ºC (104ºF).
May discolor certain fabrics, materials or surfaces.

Inactive ingredients

water, glycerin, aloe barbadensis leaf juice, carbomer, sodium hydroxide, fragrance

Package Label - Principal Display Panel

SHIMMY ORIGINAL HAND SANITIZER

8 fl oz (236 mL)

NDC: 81755-001-92

SHIMMY ORIGINAL HAND SANITIZER

9 fl oz (266 mL)

NDC: 81755-001-93

INGREDIENTS AND APPEARANCE

SHIMMY ROSE HIBISCUS HAND SANITIZER

alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81755-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
CARBOMER 940 (UNII: 4Q93RCW27E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:81755-002-92	236 mL in 1 CAN; Type 0: Not a Combination Product	06/14/2021
2	NDC:81755-002-93	266 mL in 1 CAN; Type 0: Not a Combination Product	06/14/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/14/2021

Labeler - Shimmy Products LLC (117838009)

Revised: 6/2021

Document Id: c50b6ea2-54e1-70f3-e053-2a95a90a4ac6

Set id: c50b5044-31fd-672a-e053-2995a90a49fc

Version: 1

Effective Time: 20210618