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NDC 14051-0221-17 Care 0.7 mL/mL Details

Care 0.7 mL/mL

Care is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Top Chemical Co., Inc.. The primary component is ALCOHOL.

Product Information

NDC	14051-0221
Product ID	14051-221_1cd66ecc-2248-452f-9488-68394c733ef1
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Care
Proprietary Name Suffix	n/a
Non-Proprietary Name	ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	0.7
Active Ingredient Units	mL/mL
Substance Name	ALCOHOL
Labeler Name	Top Chemical Co., Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2024-12-31

Package

Package Images

NDC 14051-0221-17 (14051022117)

Pricing Information	N/A
NDC Package Code	14051-221-17
Billing NDC	14051022117
Package	532 mL in 1 BOTTLE, PLASTIC (14051-221-17)
Marketing Start Date	2005-11-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 161e4ca7-8282-481d-b861-9c9bdb2adfd9 Details

Drug Facts Box OTC-Active Ingredient Section

Ethyl Alcohol 62%

Drug Facts Box OTC-Purpose Section

Antiseptic

Drug Facts Box OTC-Indications & Usage Section

for hand-washing to decrease bacteria on the skin, only when water is not available

Drug Facts Box OTC-Warnings Section

FLAMMABLE, keep away from fire and flames

For external use only

Drug Facts Box OTC-When Using Section

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

Drug Facts Box OTC-Stop Use Section

irritation and redness develop

Drug Facts Box OTC-Keep Out of Reach of Children Section

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

Drug Facts Box OTC-Dosage & Administration Section

wet hands thoroughly with product and allow to dry without wiping

Drug Facts Box OTC-Inactive Ingredient Section

water, diisopropylamine, carbomer, propylene glycol, DMDM hydantoin, tocopheryl acetate, aloe barbadensis

Care 6605 5 oz

Care 6605 5 oz bottle label

INGREDIENTS AND APPEARANCE

CARE

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14051-221
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARBOMER 934 (UNII: Z135WT9208)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
DIISOPROPYLAMINE (UNII: BR9JLI40NO)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14051-221-17	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2005
2	NDC:14051-221-24	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2005
3	NDC:14051-221-05	540 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2005
4	NDC:14051-221-28	149 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2005

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	11/01/2005

Labeler - Top Chemical Co., Inc. (178122677)

Registrant - ABC Compounding Co., Inc. (003284353)

Name	Address	ID/FEI	Business Operations
Establishment
ABC Compounding Co., Inc.		003284353	manufacture(14051-221)

Revised: 1/2019

Document Id: 1cd66ecc-2248-452f-9488-68394c733ef1

Set id: 161e4ca7-8282-481d-b861-9c9bdb2adfd9

Version: 4

Effective Time: 20190102