Cure Well Advanced Hand Sanitizer by BluSky Partners LLC Hand Sanitizer

Cure Well Advanced Hand Sanitizer by

Drug Labeling and Warnings

Cure Well Advanced Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by BluSky Partners LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CURE WELL ADVANCED HAND SANITIZER- ethyl alcohol gel 
BluSky Partners LLC

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

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can 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

• in children less than 2 months of age
• on open skin wounds

When Using

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 occurs. 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.

Stop Use

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.

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

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

Inactive Ingredients

acrylate copolymer, fragrance, glycerin, hydrogen peroxide, monoethanolamine, water

Cure Well 2 oz Label

59 mL NDC: 78952-070-22

Cure Well 4 oz Label

118 mL NDC: 78952-070-24

Cure Well 5 oz Label

147 mL NDC: 78952-070-25

Cure Well 8 oz Label

236 mL NDC: 78952-070-28

Cure Well 10 oz Label

295 mL NDC: 78952-070-30

Cure Well 12 oz Label

354 mL NDC: 78952-070-32

Cure Well 16 oz Label

473 mL NDC: 78952-070-26

Cure Well 1 gal Label

3785 mL NDC: 78952-070-21

Cure Well 1 oz Label

30 mL NDC: 78952-070-31

CURE WELL ADVANCED HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78952-070(NDC: 77042-770)
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
MONOETHANOLAMINE (UNII: 5KV86114PT)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)
WATER (UNII: 059QF0KO0R)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78952-070-22	0.059 L in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2020
2	NDC: 78952-070-24	0.12 L in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2020
3	NDC: 78952-070-25	0.15 L in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2020
4	NDC: 78952-070-28	0.24 L in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2020
5	NDC: 78952-070-30	0.3 L in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2020
6	NDC: 78952-070-32	0.35 L in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2020
7	NDC: 78952-070-26	0.47 L in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2020
8	NDC: 78952-070-21	3.785 L in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2020
9	NDC: 78952-070-41	0.03 L in 1 BOTTLE; Type 0: Not a Combination Product	06/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/14/2020	12/31/2022

Labeler - BluSky Partners LLC (117533754)

Revised: 7/2021

Document Id: c7bb14d3-e277-2f30-e053-2a95a90ada51

34390-5

Set id: a80ce672-5727-3c06-e053-2a95a90a3ef9

Version: 6

Effective Time: 20210722