WESTERN FAMILY ALOE VERA MOISTURIZING- lidocaine hydrochloride gel

Western Family Aloe Vera Moisturizing by

Drug Labeling and Warnings

Western Family Aloe Vera Moisturizing by is a Otc medication manufactured, distributed, or labeled by WESTERN FAMILY FOODS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine HCl   0.5%

Purpose

Topical Analgesic

Uses

• temporary relief of pain and itching
• helps relieve and soothes pain from sunburn, minor burns, cuts, scrapes, skin irritations and insect bites
  

Warnings

For external use only

Do not use

in large quantities, particularly over raw surfaces or blistered areas.

When using this product

• avoid contact with eyes
  

Stop use and ask a doctor if

• condition worsens or if symptoms persist for more than 7 days.
• symptoms clear up and occur again within a few days.
  

Keep out of reach of children

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

Directions

• adults and children 2 years of age and older: apply to affected areas not more than 3 to 4 times daily
• children under 2 years of age: do not use, ask a doctor
  

Inactive ingredients

Water, Propylene Glycol, Glycerin, Isopropyl Alcohol, Triethanolamine, Polysorbate 80, Carbomer, Aloe Barbadensis Leaf Juice Powder, Menthol, Disodium EDTA, Diazolidinyl Urea, Yellow 5, Blue 1.

Principal Display Panel

WESTERN FAMILY

Aloe Vera

MOISTURIZING GEL

Sunburn Pain Relief

with Lidocaine HCL

clean, fresh fragrance soothes and moisturizes

NET WT. 8 OZ. (226 g)

INGREDIENTS AND APPEARANCE

WESTERN FAMILY ALOE VERA MOISTURIZING 
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55312-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TROLAMINE (UNII: 9O3K93S3TK)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MENTHOL (UNII: L7T10EIP3A)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55312-012-16	226 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/02/2014

Labeler - WESTERN FAMILY FOODS, INC. (192166072)