Purespa Hand Sanitizer Spray Dandelion and Fig

Purespa Hand Sanitizer Dandelion and Fig by

Drug Labeling and Warnings

Purespa Hand Sanitizer Dandelion and Fig by is a Otc medication manufactured, distributed, or labeled by Shalom International Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURESPA HAND SANITIZER DANDELION AND FIG- alcohol spray 
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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Purespa Hand Sanitizer Spray Dandelion and Fig

Drug Facts

Active Ingredients

Alcohol Denat. 60%

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), Sodium Hydroxide, Tocopheryl Acetate, D & C Red 33, FD & C Blue 1

Questions?

  • Call 212-391-6970

Package Labeling:

Label11

PURESPA HAND SANITIZER DANDELION AND FIG 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73025-054
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.6 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)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73025-054-6060 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)

Revised: 3/2022
Document Id: d92a521c-8fab-2cd2-e053-2995a90a5614
Set id: ee75ce8e-1367-490f-8c28-904daa44e4c7
Version: 3
Effective Time: 20220301