Body by Derma Glove / Mid Lab Incorporated BODY- lotion lotion

Body by

Drug Labeling and Warnings

Body by is a Otc medication manufactured, distributed, or labeled by Derma Glove, Mid Lab Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethanol 62% v/v

PURPOSE

Antimicrobial

WARNINGS

For external use only. Flammable. Keep away from children.

WHEN USING

Do not use in or near eyes. In case of eye contact, rinse thoroughly with water.

STOP USE

If redness or irritation develop and persist for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Apply lotion directly onto body and rub with hands until dry. Product may be used on all skin surfaces. Children under 6 years of age should be supervised when using this product.

DOSAGE & ADMINISTRATION

Apply lotion directly onto body and rub with hands until dry. Product may be used on all skin surfaces. Children under 6 years of age should be supervised when using this product.

OTHER SAFETY INFORMATION

Do not store above 110oF (43oC). For additional information, see Safety Data Sheet (SDS).

INACTIVE INGREDIENT

Water (aqua), glycereth-18 (and) glycereth-18 ethylhexanoate, PEG 1450, PEG-10 dimethicone, cocamide MEA, ethylene glycol distearate, acrylate crosspolymer, fragrance (parfum), 2-amino-2-methyl-1-propanol, FD&C Blue #1.

QUESTIONS

Call 1-888-300-1225, Monday through Friday 8:00AM to 5:00PM EST/EDT.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BODY 
lotion lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70741-005
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)	30 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70741-005-03	75 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/14/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/07/2016

Labeler - Derma Glove (962709569)

Registrant - Derma Glove (962709569)

Establishment
Name	Address	ID/FEI	Business Operations
Mid Lab Incorporated		047371463	manufacture(70741-005)