DRUG FACT

SWEET CANDY KISS SANITIZER PEN - alcohol liquid
Zhejiang Blue Dream Cosmetics 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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DRUG FACT

Active Ingredient Ethyl Alcohol 62%

Purpose Antiseptic

Uses:

To decrease bacteria on skin that could cause disease

Recommended for repeated use

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.

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

Other Information

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

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

labe label

labels sweeta

SWEET CANDY KISS SANITIZER PEN
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:34460-6006
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)	0.002 g in 100 g
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.005 g in 100 g
FD&C RED NO. 40 (UNII: WZB9127XOA)	0.003 g in 100 g

#	Item Code	Package Description
Packaging
1	NDC:34460-6006-1	10 g in 1 BOTTLE
2	NDC:34460-6006-2	90 g in 1 BOTTLE

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

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

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

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