INSTANT HAND SANITIZER- instant hand sanitizer gel 
YANGZHOU OLANDE COSMETIC CO., LTD.

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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INSTANT HAND SANITIZER

Active Ingredient(s)

Ethyl alcohol 70% v/v

Purpose

antimicrobial

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease. For

use when soap and water are not available.
Recommended for repeated use.

Warnings

For external use only.
Flammable keep away from heat, fire or flame.

Do not use

Do not use children less than 2 months of age on open skin wounds.

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

Stop use or consult 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

Place enough product on hands to cover all surfaces.
Rub hands together until dry.
Use as needed no need to rinse with water.
For children under 6 years of age, use only under adult supervision.
Not recommender for infants.

Other information

Store between 15-30°C(59-86°F)
Avoid freezing and excessive heat above 40°C(104°F)

Inactive ingredients

Water, carbomer, triethanolamine

Package Label - Principal Display Panel

23660200100030010050030500080120505540

INSTANT HAND SANITIZER 
instant hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78026-015
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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78026-015-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:78026-015-0240 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:78026-015-0350 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
4NDC:78026-015-0455 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
5NDC:78026-015-0560 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
6NDC:78026-015-0680 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
7NDC:78026-015-07100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
8NDC:78026-015-08120 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
9NDC:78026-015-09200 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
10NDC:78026-015-10236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
11NDC:78026-015-11300 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
12NDC:78026-015-12500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
13NDC:78026-015-131000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
14NDC:78026-015-145000 mL in 1 BOTTLE; 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 - YANGZHOU OLANDE COSMETIC CO., LTD. (529466827)
Establishment
NameAddressID/FEIBusiness Operations
YANGZHOU OLANDE COSMETIC CO., LTD.529466827manufacture(78026-015)

Revised: 6/2020
Document Id: a715ca07-106d-fc53-e053-2995a90ad451
Set id: a66fd773-4a2f-d3d2-e053-2a95a90a83f7
Version: 2
Effective Time: 20200602
 
YANGZHOU OLANDE COSMETIC CO., LTD.