Label: ALCOHOL gel
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Contains inactivated NDC Code(s)
NDC Code(s): 73418-035-01, 73418-036-01, 73418-037-01, 73418-038-01 - Packager: Hello Bello
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 9, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT.
- PURPOSE
- USES:
- WARNINGS:
- DIRECTIONS:
- OTHER INFORMATION:
- INACTIVE INGREDIENTS:
- Principal Display Panel – 354 mL Bottle Label
- Principal Display Panel – 236 mL Bottle Label
- Principal Display Panel – 236 mL Bottle Label
- Principal Display Panel – 236 mL Bottle Label
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INGREDIENTS AND APPEARANCE
ALCOHOL
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73418-035 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 Aloe Vera Leaf (UNII: ZY81Z83H0X) Calendula Officinalis Flower (UNII: P0M7O4Y7YD) Chamomile (UNII: FGL3685T2X) Citric Acid Monohydrate (UNII: 2968PHW8QP) Glycerin (UNII: PDC6A3C0OX) Guaraprolose (1300 MPA.S AT 1%) (UNII: 1530WMS90S) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73418-035-01 354 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/01/2020 ALCOHOL
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73418-036 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Aloe Vera Leaf (UNII: ZY81Z83H0X) Glycerin (UNII: PDC6A3C0OX) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73418-036-01 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 02/01/2020 ALCOHOL
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73418-037 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Aloe Vera Leaf (UNII: ZY81Z83H0X) Glycerin (UNII: PDC6A3C0OX) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) TROLAMINE (UNII: 9O3K93S3TK) Lemon Oil (UNII: I9GRO824LL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73418-037-01 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/01/2020 ALCOHOL
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73418-038 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) TROLAMINE (UNII: 9O3K93S3TK) Lavender Oil (UNII: ZBP1YXW0H8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73418-038-01 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/01/2020 Labeler - Hello Bello (081135707) Establishment Name Address ID/FEI Business Operations Unconditional Love 081135707 MANUFACTURE(73418-035, 73418-036, 73418-037, 73418-038)