Spatherapy Hand Sanitizer

Spatherapy Hand Sanitizer by

Drug Labeling and Warnings

Spatherapy Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Shalom International Corp, Xiamen Triz Laboratories Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPATHERAPY HAND SANITIZER- 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 Hand Sanitizer

Drug Facts

Active Ingredients

Alcohol Denat. 62%

Purpose

Antibacterial

Uses

  • Hand sanitizer to help reduce bacteria on the skin that could cause disease.
  • Recommended for repeated use.

Warnings

  • Flamable. Keep away from fire or flame.
  • For external use only

When using this product 

  • do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use & ask a doctor

  • if irritation or rash appears & lasts.

Keep out of reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply enough product to thoroughly cover hands.
  • Rub hands together briskly until dry.

Other Information

  • Do not store above 110°F (43°C).
  • May discolor certain fabrics or surfaces.

Inactive Ingredients

Water (Aqua), PEG-40 Hydrogenated Castor Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, DMDM Hydantoin, Fragrance(Parfum), Aloe Barbadensis Leaf Extract, Sodium Hydroxide, Tocopheryl Acetate.

Questions?

  • Call 212-391-6970

Package Labeling:73025-061-11

Label4

Package Labeling: 73025-061-26

Label260

SPATHERAPY HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73025-061
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)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73025-061-11110 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/202012/31/2021
2NDC: 73025-061-26260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/202012/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/01/202012/31/2021
Labeler - Shalom International Corp (001384825)
Establishment
NameAddressID/FEIBusiness Operations
Xiamen Triz Laboratories Ltd.421290822manufacture(73025-061)

Revised: 4/2022
Document Id: dcf2e833-8162-38f7-e053-2a95a90a40b4
Set id: 86694b1f-737a-4515-93e8-3ee4f0c7a6af
Version: 4
Effective Time: 20220418