ORCHID AND ME MOISTURIZING HAND SANITIZER- alcohol gel 
ORCHID & ME ORGANICS & PRODUCTS COMPANY LIMITED

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

Alcohol 77% v/v.

Purpose

Antiseptic

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

in children less than 2 months of age and 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.

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 at 1-800222-1222.

Directions

Other information

Questions?

1-800-571-8254 Mon-Fri 9:00 AM- 5:00 PM (EST)

Inactive ingredients

Aqua, Avena sativa Kernel Oil, Carbomer, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Medica Limonum (Lemon) Peel Oil, Galactoarabinan, Glycerin, Honey, Sodium Hyaluronate, Triethanolamine

Package Label - Principal Display Panel

Label

ORCHID AND ME MOISTURIZING HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90018-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL77 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
HONEY (UNII: Y9H1V576FH)  
GALACTOARABINAN (UNII: SL4SX1O487)  
TROLAMINE (UNII: 9O3K93S3TK)  
ORANGE OIL (UNII: AKN3KSD11B)  
LEMON OIL (UNII: I9GRO824LL)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
OAT KERNEL OIL (UNII: 3UVP41R77R)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:90018-002-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
2NDC:90018-002-02100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
3NDC:90018-002-03250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2020
4NDC:90018-002-04500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2020
5NDC:90018-002-051000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2020
6NDC:90018-002-06300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2020
7NDC:90018-002-07310 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2020
8NDC:90018-002-08330 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/01/2020
Labeler - ORCHID & ME ORGANICS & PRODUCTS COMPANY LIMITED (662953398)

Revised: 10/2020
Document Id: fb2ddae5-2235-40e0-911a-a64e9ba5df52
Set id: c6a6b88b-5f53-4d61-b3b6-61ed16490b9c
Version: 2
Effective Time: 20201027
 
ORCHID & ME ORGANICS & PRODUCTS COMPANY LIMITED