HUMCO GLYCERIN AND ARTIFICIAL ROSE WATER- glycerin liquid 
Humco Holding Group, Inc.

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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Humco Glycerin and Artificial Rose Water

Drug Facts

Active ingredient

Glycerin 10%

Purpose

Skin protectant

Use

Helps prevent and temporarily protects chafed, chapped, cracked or windburned skin and lips.

Warnings

Do not apply over deep wounds or puncture woonds, infections or lacerations unless directed by a doctor.

Do not use in children under 6 months of age unless directed by a doctor.

Avoid contact with eye.

When using this product.

discontinue use if condition worsens or does not improve withn 7 days and consult a doctor.

Keep out of reach of children.

In case of accidental overdose, seek professional assisatance or contact a Poison Control Center immediatley.

In case of eye contact, flush eyes with runing water for 15 minutes.

Directiions

Dilute with equal amount of water and apply liberally as often as necessary.

Inactive ingredients

Artificial rose fragrance, propylene glycol, polysorbate 80, sodium benzoate and purified water.

Principal display panel

Gly & Art Rosewater.jpg

HUMCO GLYCERIN AND ARTIFICIAL ROSE WATER 
glycerin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-1037
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0395-1037-96177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/13/201701/16/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34603/25/199801/16/2019
Labeler - Humco Holding Group, Inc. (825672884)
Registrant - Pharma Nobis, LLC (118564114)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Nobis, LLC118564114manufacture(0395-1037) , analysis(0395-1037) , pack(0395-1037) , label(0395-1037)

Revised: 3/2022
 
Humco Holding Group, Inc.