SIGNATURE CARE ALOE VERA GEL WITH LIDOCAINE- lidocaine gel

Signature Care Aloe Vera Gel with Lidocaine by

Drug Labeling and Warnings

Signature Care Aloe Vera Gel with Lidocaine by is a Otc medication manufactured, distributed, or labeled by Safeway, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine 0.8% (as Lidocaine HCI)

Purpose

External Analgesic

Uses

For the temporary relief of pain and itching associated with sunburn, minor burns, minor cuts, scrapes, insect bites, and minor skin irritations

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. If contact occurs, rinse with water to remove.

Stop use and ask a doctor if

condition worsens 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, seek medical help or contact a Poison Control Center immediately.

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily

Children under 2 years of age: Ask a doctor.

Inactive ingredients

water, aloe barbadensis leaf juice, SD alcohol 40-B, propylene glycol, laureth-23, polysorbate 20, glycerin, allantoin, tocopheryl acetate (vitamin E acetate), retinyl palmitate (vitamin A palmitate) tocopherol, carbomer, triethanolamine, menthyl lactate,diazolidinyl urea, disodium EDTA, menthol, fragrance, aleurites moluccanus seed extract, carica papaya (papaya) fruit extract, colocasia antiquorum root extract, mangifera indica (mango) fruit extract, passiflora incarnata flower extract, plumeria acutifolia flower extract, psidium guajava fruit extract, fragrance, blue 1, yellow 5.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SIGNATURE CARE ALOE VERA GEL WITH LIDOCAINE 
lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-733
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	8 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
MANGO (UNII: I629I3NR86)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LAURETH-23 (UNII: N72LMW566G)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALLANTOIN (UNII: 344S277G0Z)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LEVOMENTHOL (UNII: BZ1R15MTK7)
KUKUI NUT OIL (UNII: TP11QR7B8R)
PAPAYA (UNII: KU94FIY6JB)
COLOCASIA ESCULENTA ROOT (UNII: H7B71Q0G0D)
PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z)
GUAVA (UNII: 74O70D6VG0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
PLUMERIA ALBA FLOWER OIL (UNII: T69Z2432CU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-733-68	454 g in 1 BOTTLE; Type 0: Not a Combination Product	12/14/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/14/2011

Labeler - Safeway, Inc. (009137209)