FROSTED BERRIES AND CREAM SANITIZER PEN- alcohol liquid

Frosted Berries and Cream Sanitizer Pen by

Drug Labeling and Warnings

Frosted Berries and Cream Sanitizer Pen by is a Otc medication manufactured, distributed, or labeled by Zhejiang Blue Dream Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient      Ethyl Alcohol     62%

Purpose                      Antiseptic 

DESCRIPTION

Uses: 

To decrease bacteria on skin that could cause disease

Recommended for repeated use

WARNINGS

Warnings:

For external use only

Flammable. Keep away from heat and flame.

When using this product

• Keep out of eyes.  In case of contact with eyes, flush thoroughly with water
• Avoid contact with broken skin
• Do not inhale or ingest
  

Stop use and ask a doctor if skin irritation develops

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions:

• Wet hands thoroughly with product and allow to dry without wiping
  
• For children under 6, use only under adult supervision.
• Not recommended for infants
  

STORAGE AND HANDLING

Other Information

• Do not store above 105F
• May discolor some fabrics
• Harmful to wood finishes and plastics

INACTIVE INGREDIENT

Inactive Ingredients:

Water, Glycerin, Triethanolamine, Carbomer, Fragrance, PEG-40 Hydrogenated Castor Oil, DMDM Hydantoin, Hydrogenated Jojoba Oil, FDA and C Blue No. 1, FD and C Red No. 40, FD and C Yellow No. 5

PRINCIPAL DISPLAY PANEL

label

PRINCIPAL DISPLAY PANEL

back

INGREDIENTS AND APPEARANCE

FROSTED BERRIES AND CREAM SANITIZER PEN 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34460-6005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	35.16 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	2.0 g  in 100 g
TROLAMINE (UNII: 9O3K93S3TK)	0.2 g  in 100 g
CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC)	0.2 g  in 100 g
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)	0.1 g  in 100 g
DMDM HYDANTOIN (UNII: BYR0546TOW)	0.2 g  in 100 g
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)	0.003 g  in 100 g
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.002 g  in 100 g
FD&C RED NO. 40 (UNII: WZB9127XOA)	0.005 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34460-6005-1	10 g in 1 BOTTLE
2	NDC: 34460-6005-2	90 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	08/07/2010

Labeler - Zhejiang Blue Dream Cosmetics Co., Ltd. (529047234)

Registrant - Zhejiang Blue Dream Cosmetics Co., Ltd. (529047234)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Blue Dream Cosmetics Co., Ltd.		529047234	manufacture