Label: ALOE ICE SUNBURN RELIEF- lidocaine hydrochloride gel
- NDC Code(s): 61477-101-11, 61477-101-14
- Packager: Aloe Care International, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 13, 2024
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- ACTIVE INGREDIENTS
- PURPOSE
- USES
- DIRECTIONS
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
- STOP USE
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALOE ICE SUNBURN RELIEF
lidocaine hydrochloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61477-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA WHOLE (UNII: KIZ4X2EHYX) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) CARBOMER 934 (UNII: Z135WT9208) EDETATE DISODIUM (UNII: 7FLD91C86K) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61477-101-14 120 mL in 1 TUBE; Type 0: Not a Combination Product 02/24/2014 2 NDC:61477-101-11 60 mL in 1 TUBE; Type 0: Not a Combination Product 02/24/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 02/24/2014 Labeler - Aloe Care International, LLC (938242187)