SD NATURALS HAND SANITIZER UNSCENTED by SPA DENT INC. / Spa Dent Inc.

SD NATURALS HAND SANITIZER UNSCENTED by

Drug Labeling and Warnings

SD NATURALS HAND SANITIZER UNSCENTED by is a Otc medication manufactured, distributed, or labeled by SPA DENT INC., Spa Dent Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SD NATURALS HAND SANITIZER UNSCENTED- alcohol gel 
SPA DENT INC.

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Active Ingredient(s)

Alcohol 80% 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 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 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.

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

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

SD NATURALS HAND SANITIZER UNSCENTED 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79147-007
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)
WATER (UNII: 059QF0KO0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ALOE (UNII: V5VD430YW9)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
HYALURONIC ACID (UNII: S270N0TRQY)
CARBOMER COPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 1N11AG4X4L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79147-007-01	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	03/15/2020	03/25/2021

Labeler - SPA DENT INC. (203478896)

Establishment
Name	Address	ID/FEI	Business Operations
Spa Dent Inc.		203478896	manufacture(79147-007) , pack(79147-007) , label(79147-007)

Revised: 6/2024

Document Id: 1a2a410d-3228-396d-e063-6294a90ab98b

34390-5

Set id: bd99ad3b-7fe7-7ff6-e053-2a95a90a20e9

Version: 4

Effective Time: 20240605