BROMPTON AND LANGLEY HAND SANITIZER- alcohol gel
Xiamen Afgamarine Biotechnology 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 Facts

Active ingredient

Alcohol 70% w/w

Purpose

Antiseptic

Use

Antiseptic Cleanser, helps decrease bacteria on skin.

Warnings

For external use only. Flammable. Keep product away from fire or flame.

When using this product

Avoid contact with the eyes; in case of contct, flush eyes with water.

Stop use and ask a doctor if

Irritation or redness develops and persists.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Place enough product on your palm to thoroughly cover your hands.
Rub hands together briskly until dry.
Children under 6 years of age should be supervised when using this product.

Other information

Store below 110°F (43°C). May discolor certain fabrics or surfaces.

Inactive ingredients

Aqua/Water/Eau, Glycerin, Carbomer, Triethanolamine, Fragrance (Parfum).

Questions?

1-800-548-4097

Label copy

Image of the label

BROMPTON AND LANGLEY HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77607-005
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	700 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 934 (UNII: Z135WT9208)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:77607-005-01	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/06/2021
2	NDC:77607-005-02	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/06/2021
3	NDC:77607-005-03	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/06/2021
4	NDC:77607-005-04	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/06/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	10/06/2021

Labeler - Xiamen Afgamarine Biotechnology Co., Ltd. (420485152)

Registrant - Xiamen Afgamarine Biotechnology Co., Ltd. (420485152)

Name	Address	ID/FEI	Business Operations
Establishment
Xiamen Afgamarine Biotechnology Co., Ltd.		420485152	manufacture(77607-005)