OTC Medication Information: Ultima DET Antiseptic

ULTIMA DET ANTISEPTIC- chloroxylenol liquid
ATLANTIC CARE CHEMICALS PRIVATE LIMITED

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 Facts

Purpose: Antiseptic

ACTIVE INGREDIENTS

Component

Chloroxylenol — 5 %

INACTIVE INGREDIENTS

Isopropyl alcohol, Castor oil, Pine oil, Lauryl alcohol ethoxylate, Methyl ester sulfonate, Water, Caramel colour E150d

Use: This product is a specially formulated hand wash soap for hygiene hand washing to decrease microbes on the skin. This concentrated antiseptic hand wash liquid should be diluted with water (1:5 ml) before use.

Directions: Wet hand with fresh water and apply soap. Rub hand together for 20 sec. Rinse hands thoroughly with fresh water.

When using this product: keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor: if irritation occurs, please consult a doctor.

Do not use

• In children less than 2 months of age.

• On open skin wounds.

Warning

• For external use only

• Keep out of Reach of Children

Other information

• Store between 15-30°C (59-86F)

• Avoid freezing and excessive heat above 50°C (104F)

Manufactured by:
Atlantic Care Chemicals. Pvt. Ltd
Industrial Development Plot,
Alappuzha, Kerala, India.

9001:2015

ISO CERTIFIED COMPANY

PASSION FOR INNOVATION

care@atlanticchemicals.com
www.atlanticchemicals.com

MADE IN INDIA

Packaging

Ultma1
(click image for full-size original)

ULTIMA DET ANTISEPTIC
chloroxylenol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:77249-107
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL 50 g in 1 L
Inactive Ingredients
Ingredient Name Strength
ISOPROPYL ALCOHOL
CASTOR OIL
WHITE PINE OIL
LAURYL ALCOHOL
S-METHYL METHANETHIOSULFONATE
WATER
CARAMEL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:77249-107-45 5 L in 1 CAN None
2 NDC:77249-107-01 0.1 L in 1 BOTTLE None
3 NDC:77249-107-02 0.2 L in 1 BOTTLE None
4 NDC:77249-107-05 0.5 L in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 05/15/2020
Labeler — ATLANTIC CARE CHEMICALS PRIVATE LIMITED (861499902)
Establishment
Name Address ID/FEI Operations
ATLANTIC CARE CHEMICALS PRIVATE LIMITED 861499902 manufacture (77249-107)

Revised: 05/2020 ATLANTIC CARE CHEMICALS PRIVATE LIMITED

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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