Drug Fact

DOTS APPLE CINNAMON ANTI-BACTERIAL HAND SANITIZER - alcohol liquid
ALILY (ZHANGZHOU) BATH PRODUCTS 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 Purpose

Ethyl Alcohol 62% Antiseptic

Uses:

To decrease bacteria on the skin that could cause diseases

Recommended for repeated use.

Warnings:

For external use only-hands.

Flammable-keep away from heat and flame

When using this products

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 105 F
May discolor some fabrics
Harmful to wood finishes and plastics

Inactive Ingredients

Water (aqua), Glycerin, Triethanolamine, Fragrance (Parfume), PEG-40 Hydrogenated Castor Oil, Carbomer, DMDM Hydantoin, Hydrogenated Jojoba Oil, FD and C Red No. 40, D and C Red No. 33

pictu Label picture

DOTS APPLE CINNAMON ANTI-BACTERIAL HAND SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49371-034
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)	33.9486 g in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	2 g in 100 g
TROLAMINE (UNII: 9O3K93S3TK)	0.3 g in 100 g
CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC)	0.3 g in 100 g
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)	0.8 g in 100 g
DMDM HYDANTOIN (UNII: BYR0546TOW)	0.2 g in 100 g
FD&C RED NO. 40 (UNII: WZB9127XOA)	0.006 g in 100 g
D&C RED NO. 33 (UNII: 9DBA0SBB0L)	0.0004 g in 100 g
APPLE (UNII: B423VGH5S9)	0.2 g in 100 g
CINNAMON (UNII: 5S29HWU6QB)	0.2 g in 100 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49371-034-01	45 g in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333	05/20/2010

Labeler - ALILY (ZHANGZHOU) BATH PRODUCTS LTD. (531064269)

Registrant - ALILY (ZHANGZHOU) BATH PRODUCTS LTD. (531064269)

Name	Address	ID/FEI	Business Operations
Establishment
ALILY (ZHANGZHOU) BATH PRODUCTS LTD.		531064269	manufacture