100% Pure Hand Sanitizer Hydrating Gel

100% Pure Hand Sanitizer by

Drug Labeling and Warnings

100% Pure Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Purity Cosmetics, Our Babylon LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

100% PURE HAND SANITIZER HYDRATING- ethyl alcohol gel 
Purity Cosmetics

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100% Pure Hand Sanitizer Hydrating Gel

Active Ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

For cleaning hands when water is not available to help reduce bacteria on the skin. Recommended for repeated use.

Warnings:

  • ​For external use only.

  • Flammable, keep away from fire, sparks, and sources of ignition.
  • Do not store above 104°F/40°C.

  • When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water.

  • ​ Keep out of reach of children. ​If swallowed, get medical help or contact a Poison Control Center immediately.

  • Avoid contact with broken skin.

  • Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Directions:

Dispense directly on hands and rub in thoroughly. For children under 6, use adult supervision. Not recommended for infants.

Other Ingredients:

Aloe Barbadensis (Aloe Vera) Leaf Juice*, Glycerin, Hydroxypropyl Guar, Citric Acid, Aqua (Water) *Organic Ingredient

Questions or Comments?

Call 1.415.814.9788 or visit www.100PercentPure.com

100% Pure Hand Sanitizer Hydrating Gel

Product NDC: 52667-011 Label

100% PURE HAND SANITIZER  HYDRATING
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 52667-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
GUARAPROLOSE (1300 MPA.S AT 1%) (UNII: 1530WMS90S)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 52667-011-0150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/202002/09/2025
2NDC: 52667-011-02473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/202002/09/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)08/03/202002/09/2025
Labeler - Purity Cosmetics (055795259)
Registrant - Our Babylon LLC (105266218)
Establishment
NameAddressID/FEIBusiness Operations
Our Babylon LLC105266218manufacture(52667-011)

Revised: 12/2024
Document Id: 29a4f3ff-0672-fa15-e063-6394a90af13d
Set id: abbe7ae3-bd3a-2089-e053-2a95a90af707
Version: 2
Effective Time: 20241219
 
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