Red Wings Hand Sanitizer Gel by RED WINGS INDUSTRIAL CO., LIMITED / G & A M COSMETICOS LTDA

Red Wings Hand Sanitizer Gel by

Drug Labeling and Warnings

Red Wings Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by RED WINGS INDUSTRIAL CO., LIMITED, G & A M COSMETICOS LTDA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

RED WINGS HAND SANITIZER GEL- alcohol gel 
RED WINGS INDUSTRIAL CO., LIMITED

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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This is a hand sanitizer manufactured with the following ingredients:

1. Alcohol (ethanol)
2. Water
3. Glycerin
4. Cellulose
5. Panthenol

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Ethyl alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

To decrease bacteria on the skin that could cause disease

recommended for repeated use.

Warnings

For external use only.

Flammable, keep away from heat or flame

When using this product:

avoid contact with eyes, ears, and mouth. If contact occurs, flush thoroughly with water

avoid contact with broken skin

Do not use

• on children less than 2 months of age
• if pregnant without consulting your doctor first

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.

keep out of reach of pets

Directions

• Apply a small portion on your hands, rub well and allow to dry without wiping
• Use only as directed.

Other information

Store between 59-86°F

Avoid freezing and excessive heat above 104°F

May discolor certain fabrics or surfaces

Inactive ingredients

Water, Glycerin, Cellulose, Panthenol

Package Label including Principal Display Panel

Red Wings Hand Sanitizer Gel

500 mL NDC: 81517-101-01

RED WINGS HAND SANITIZER GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81517-101
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CELLULOSE, OXIDIZED (UNII: 44AIH82TSC)
WATER (UNII: 059QF0KO0R)
PANTHENOL (UNII: WV9CM0O67Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81517-101-01	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/01/2020	12/31/2021

Labeler - RED WINGS INDUSTRIAL CO., LIMITED (664490623)

Establishment
Name	Address	ID/FEI	Business Operations
G & A M COSMETICOS LTDA		900930720	manufacture(81517-101)

Revised: 4/2022

Document Id: db9f071b-85f7-061f-e053-2995a90a3ff5

34390-5

Set id: bbb65582-6c79-58a7-e053-2995a90a778b

Version: 2

Effective Time: 20220401