SIGNATURE CARE ALOE VERA GEL WITH LIDOCAINE- lidocaine gel 
Safeway, Inc.

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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Safeway Signature Care Aloe Vera Gel with Lidocaine

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.

SY74630E4&F4

SIGNATURE CARE ALOE VERA GEL WITH LIDOCAINE 
lidocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-733
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS8 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-733-68454 g in 1 BOTTLE; Type 0: Not a Combination Product12/14/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/14/2011
Labeler - Safeway, Inc. (009137209)

Revised: 1/2022
Document Id: d50695c6-c237-efb6-e053-2995a90aff04
Set id: d5069622-97b1-ba12-e053-2a95a90a7268
Version: 1
Effective Time: 20220107
 
Safeway, Inc.