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 Chengda Industrial Co.,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), Glycerin, PEG-40 Hydrogenated Castor Oil, Carbomer, Phenoxyethanol, Benzyl Alcohol, Fragrance(Parfum), Sodium Hydroxide, Aloe Barbadensis Leaf Extract,

Questions?

  • Call 212-391-6970

Package Labeling: 73025-062-12

Label5

Package Labeling: 73025-062-25

Label250

SPATHERAPY HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73025-062
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73025-062-12120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/202006/01/2020
2NDC: 73025-062-25250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/202006/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/01/202006/01/2020
Labeler - Shalom International Corp (001384825)
Establishment
NameAddressID/FEIBusiness Operations
Xiamen Chengda Industrial Co.,Ltd 540042034manufacture(73025-062)

Revised: 1/2022
Document Id: d608c2bd-d012-95f3-e053-2a95a90a513b
Set id: 11b495e5-c366-4972-939c-5af3097c43e0
Version: 5
Effective Time: 20220120