HAND SANITIZER- alcohol gel 
Hidden Springs Manufacturing LLC.

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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Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

water, glycerin, carbomer, propylene glycol, squalane, fragrance, aloe barbadensis leaf juice, tocopheryl acetate

Package Label - Principal Display Panel

010 mL NDC: 78614-435-10

10mL label

030 mL NDC: 78614-435-30

30 mL label

050 mL NDC: 78614-435-50

050 mL NDC: 78614-435-50

050 mL NDC: 78614-435-50

118 mL NDC: 78614-435-04

118 mL NDC: 78614-435-04

473 mL NDC: 78614-435-16

473 mL label

473 mL NDC: 78614-435-16

1892 mL NDC: 78614-435-64

1892 mL NDC: 78614-435-64

236 mL NDC: 78614-435-08

8oz label

236 mL NDC: 78614-435-08

3785 mL NDC: 78614-435-28

3785 mL NDC: 78614-435-28

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78614-435
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
SQUALANE (UNII: GW89575KF9)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78614-435-1010 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/30/2020
2NDC:78614-435-3030 mL in 1 TUBE; Type 0: Not a Combination Product03/30/2020
3NDC:78614-435-5050 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
4NDC:78614-435-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
5NDC:78614-435-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
6NDC:78614-435-641892.71 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
7NDC:78614-435-08236.59 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2020
8NDC:78614-435-283785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Hidden Springs Manufacturing LLC. (122841764)
Establishment
NameAddressID/FEIBusiness Operations
HIDDEN SPRINGS MFG., CO. LLC122841764manufacture(78614-435)

Revised: 6/2020
Document Id: a706164d-fa68-82a4-e053-2a95a90a06ae
Set id: a706164d-fa79-82a4-e053-2a95a90a06ae
Version: 1
Effective Time: 20200601
 
Hidden Springs Manufacturing LLC.