Spatherapy Antibacterial Hand Gel Berry

Spatherapy Antibacterial Berry by

Drug Labeling and Warnings

Spatherapy Antibacterial Berry by is a Otc medication manufactured, distributed, or labeled by Shalom International Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPATHERAPY ANTIBACTERIAL BERRY- alcohol gel 
Shalom International Corp

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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Spatherapy Antibacterial Hand Gel Berry

Drug Facts

Active ingredient

Alcohol Denat. 62%

Purpose

Antibacterial

Use

To decrease bacteria on the skin and clean hands. Recommended for repeated use.

Warnings

For external use only.

Flammable, keep away from flames.

When using this product

do not get into eye. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

irritation or redness develop or persists for more than 72 hours

Keep out of reach of children.

Directions

Apply to hands until thoroughly wet. Rub vigorously until dry.

Inactive ingredients

Water, PEG-40 Hydrogenated Cater Oil, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer. DMDM Hydantoin, Fragrance (Parfum), Sodium Hydroxide, Tocopherol Acetate. FD&C Red 4, FD&C Blue 1.

Package Labeling:

Bottle

SPATHERAPY ANTIBACTERIAL BERRY 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73025-150
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73025-150-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/202012/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E12/01/202012/31/2020
Labeler - Shalom International Corp (001384825)

Revised: 3/2022
Document Id: d93440d3-d6c4-7d9e-e053-2a95a90a06f8
Set id: b453a725-ea13-cbee-e053-2995a90a7d45
Version: 2
Effective Time: 20220301